Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT00068692
Status:
COMPLETED
Last Update Posted:
2018-12-04
First Post:
2003-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Peru', 'Puerto Rico', 'South Africa']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eatrials@jimmy.harvard.edu', 'title': 'Statistician', 'organization': 'ECOG-ACRIN statistical office'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years', 'description': 'Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).', 'eventGroups': [{'id': 'EG000', 'title': 'Arm S', 'description': 'Preoperative chemo/radiation therapy received by Group I patients in step 1', 'otherNumAtRisk': 123, 'deathsNumAtRisk': 123, 'otherNumAffected': 27, 'seriousNumAtRisk': 123, 'deathsNumAffected': 1, 'seriousNumAffected': 62}, {'id': 'EG001', 'title': 'Group I, Arm I', 'description': 'Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nRadiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Irinotecan: Given IV', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 7, 'seriousNumAtRisk': 27, 'deathsNumAffected': 8, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Group I, Arm II', 'description': 'Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nRadiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Given IV', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 3, 'seriousNumAtRisk': 22, 'deathsNumAffected': 12, 'seriousNumAffected': 14}, {'id': 'EG003', 'title': 'Group I, Arm III', 'description': 'Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nRadiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 3, 'seriousNumAtRisk': 28, 'deathsNumAffected': 11, 'seriousNumAffected': 10}, {'id': 'EG004', 'title': 'Group II, Arm I', 'description': 'Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.\n\nTreatment continues in the absence of disease progression or unacceptable toxicity.\n\nRadiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Irinotecan: Given IV', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 6, 'seriousNumAtRisk': 31, 'deathsNumAffected': 11, 'seriousNumAffected': 21}, {'id': 'EG005', 'title': 'Group II, Arm II', 'description': 'Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.\n\nTreatment continues in the absence of disease progression or unacceptable toxicity.\n\nRadiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Given IV', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 6, 'seriousNumAtRisk': 33, 'deathsNumAffected': 9, 'seriousNumAffected': 23}, {'id': 'EG006', 'title': 'Group II, Arm III', 'description': 'Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nRadiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 12, 'seriousNumAtRisk': 32, 'deathsNumAffected': 10, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Leukocytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Neutrophils decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Platelets decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Hand-foot reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Diarrhea w/o prior colostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Muco/stomatitis by exam, oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Muco/stomatitis (symptom) oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Neuropathy-sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Abdomen, pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}], 'seriousEvents': [{'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Leukocytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Neutrophils decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Platelets decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Hematologic-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Cardiac-ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, 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[{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Hiccoughs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Incontinence urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '3-year Overall Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Irinocetan (Arm I)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received irinocetan plus 5-FU and leucovorin.'}, {'id': 'OG001', 'title': 'Oxaliplatin (Arm II)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received oxaliplatin plus 5-FU and leucovorin.'}, {'id': 'OG002', 'title': 'Control (Arm III)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group only received 5-FU and leucovorin.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.965', 'groupId': 'OG000', 'lowerLimit': '0.868', 'upperLimit': '0.991'}, {'value': '0.843', 'groupId': 'OG001', 'lowerLimit': '0.721', 'upperLimit': '0.915'}, {'value': '0.870', 'groupId': 'OG002', 'lowerLimit': '0.757', 'upperLimit': '0.933'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'One-sided p value was reported', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'stratified on ECOG performance status, clinical stage, timing of chemoradiotherapy, and regimen administration'}, {'pValue': '0.69', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'one-sided p value was reported', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'stratified on ECOG performance status, clinical stage, timing of chemoradiaotherapy, regimen administration'}], 'paramType': 'NUMBER', 'timeFrame': 'assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 years', 'description': 'Overall survival (OS) was defined as time from randomization to death from any cause. 3-year OS rate was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'proportion of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients'}, {'type': 'SECONDARY', 'title': '3-year Disease Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Irinocetan (Arm I)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received irinocetan plus 5-FU and leucovorin.'}, {'id': 'OG001', 'title': 'Oxaliplatin (Arm II)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined.Patients in this group received oxaliplatin plus 5-FU and leucovorin.'}, {'id': 'OG002', 'title': 'Control (Arm III)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group only received 5-FU and leucovorin.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.670', 'groupId': 'OG000', 'lowerLimit': '0.533', 'upperLimit': '0.776'}, {'value': '0.717', 'groupId': 'OG001', 'lowerLimit': '0.580', 'upperLimit': '0.816'}, {'value': '0.704', 'groupId': 'OG002', 'lowerLimit': '0.572', 'upperLimit': '0.802'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 years', 'description': 'Disease free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer and death from any cause, whichever occurred first. 3-year DFS rate was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'proportion of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients'}, {'type': 'SECONDARY', 'title': 'Proportion of Sphincter Preservation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Irinocetan (Arm I)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received irinocetan plus 5-FU and leucovorin.'}, {'id': 'OG001', 'title': 'Oxaliplatin (Arm II)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received oxaliplatin plus 5-FU and leucovorin.'}, {'id': 'OG002', 'title': 'Control (Arm III)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group only received 5-FU and leucovorin.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.814', 'groupId': 'OG000', 'lowerLimit': '0.691', 'upperLimit': '0.903'}, {'value': '0.724', 'groupId': 'OG001', 'lowerLimit': '0.591', 'upperLimit': '0.833'}, {'value': '0.655', 'groupId': 'OG002', 'lowerLimit': '0.519', 'upperLimit': '0.775'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'assessed at primary surgery time', 'description': 'Proportion of sphincter preservation was defined as number of patients with sphincter preservation divided by total number of patients randomized to the arm', 'unitOfMeasure': 'proportion of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients'}, {'type': 'SECONDARY', 'title': 'Failure Pattern', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Irinocetan (Arm I)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received irinocetan plus 5-FU and leucovorin.'}, {'id': 'OG001', 'title': 'Oxaliplatin (Arm II)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received oxaliplatin plus 5-FU and leucovorin.'}, {'id': 'OG002', 'title': 'Control (Arm III)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group only received 5-FU and leucovorin.'}], 'classes': [{'title': 'Local/regional recurrence only', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Distant recurrence only', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Both local/regional and distant recurrence', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any recurrence', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Second primary cancer', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years', 'description': 'Type of failures (local/regional recurrence vs. distant recurrence vs. concurrent recurrence vs. second primary cancer vs. deaths) in the analysis population', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I, Arm S', 'description': 'Group I patients receive concurrent chemotherapy and radiation prior to surgery.'}, {'id': 'FG001', 'title': 'Group II, Arm T', 'description': 'Patients who had surgery before registering to the study was in Group II. They were registered and randomized at the same time.'}, {'id': 'FG002', 'title': 'Group I, Arm I', 'description': 'Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nRadiotherapy: Undergo external beam radiation therapy\n\nFluorouracil: Given IV\n\nLeucovorin Calcium: Given IV\n\nIrinotecan: Given IV'}, {'id': 'FG003', 'title': 'Group I, Arm II', 'description': 'Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nRadiotherapy: Undergo external beam radiation therapy\n\nFluorouracil: Given IV\n\nLeucovorin Calcium: Given IV\n\nOxaliplatin: Given IV'}, {'id': 'FG004', 'title': 'Group I, Arm III', 'description': 'Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nRadiotherapy: Undergo external beam radiation therapy\n\nFluorouracil: Given IV\n\nLeucovorin Calcium: Given IV'}, {'id': 'FG005', 'title': 'Group II, Arm I', 'description': 'Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.\n\nTreatment continues in the absence of disease progression or unacceptable toxicity.\n\nRadiotherapy: Undergo external beam radiation therapy\n\nFluorouracil: Given IV\n\nLeucovorin Calcium: Given IV\n\nIrinotecan: Given IV'}, {'id': 'FG006', 'title': 'Group II, Arm II', 'description': 'Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.\n\nTreatment continues in the absence of disease progression or unacceptable toxicity.\n\nRadiotherapy: Undergo external beam radiation therapy\n\nFluorouracil: Given IV\n\nLeucovorin Calcium: Given IV\n\nOxaliplatin: Given IV'}, {'id': 'FG007', 'title': 'Group II, Arm III', 'description': 'Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nRadiotherapy: Undergo external beam radiation therapy\n\nFluorouracil: Given IV\n\nLeucovorin Calcium: Given IV'}], 'periods': [{'title': 'Step 1: Registration', 'milestones': [{'type': 'STARTED', 'comment': 'Randomization (arms I-III in both groups) was step 2.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'comment': 'Group II patients were registered and randomized at the same time, and were reported in Step 2.', 'groupId': 'FG001', 'numSubjects': '97'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Group II patients was registered and randomized at the same time, and reported in step 2', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'Group II patients was registered and randomized at the same time, and reported in step 2', 'groupId': 'FG006', 'numSubjects': '0'}, {'comment': 'Group II patients was registered and randomized at the same time, and reported in step 2', 'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Started Concurrent Chemo/Radiation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'comment': 'Group II patients receive protocol therapy in Step 2 after randomization', 'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Reported AE Data', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Of the 88 patients completed step 1 treatment, 5 of them decided not to randomize to step 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'comment': 'Case 32191 entered the study as Group II patient but was never randomized.', 'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Disese progression/relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Alternative therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Complicating disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Not eligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Not start protocol therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Registered but not randomized', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Step 2: Randomization', 'milestones': [{'type': 'STARTED', 'comment': 'Randomization (arms I-III in both groups) was step 2.', 'achievements': [{'comment': 'Patients on arm S completing step 1 treatment were randomized to step 2 (Arms I-III).', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Group II patients were registered and randomized at the same time, reported as arms I,II,III here.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Of the 128 patients registered to step 1in group 1, 83 were randomized to step 2(arms I-III).', 'groupId': 'FG002', 'numSubjects': '28'}, {'comment': 'Of the 128 patients registered to step 1in group 1, 83 were randomized to step 2(arms I-III).', 'groupId': 'FG003', 'numSubjects': '25'}, {'comment': 'Of the 128 patients registered to step 1in group 1, 83 were randomized to step 2(arms I-III).', 'groupId': 'FG004', 'numSubjects': '30'}, {'comment': 'Group 2 patients were registered and randomized at the same time.', 'groupId': 'FG005', 'numSubjects': '31'}, {'comment': 'Group 2 patients were registered and randomized at the same time.', 'groupId': 'FG006', 'numSubjects': '33'}, {'comment': 'Group 2 patients were registered and randomized at the same time.', 'groupId': 'FG007', 'numSubjects': '32'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '29'}, {'groupId': 'FG005', 'numSubjects': '31'}, {'groupId': 'FG006', 'numSubjects': '33'}, {'groupId': 'FG007', 'numSubjects': '32'}]}, {'type': 'Had Sphincter Preservation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'groupId': 'FG005', 'numSubjects': '31'}, {'groupId': 'FG006', 'numSubjects': '33'}, {'groupId': 'FG007', 'numSubjects': '30'}]}, {'type': 'Reported AE Data', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'groupId': 'FG005', 'numSubjects': '31'}, {'groupId': 'FG006', 'numSubjects': '33'}, {'groupId': 'FG007', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '25'}, {'groupId': 'FG006', 'numSubjects': '29'}, {'groupId': 'FG007', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Disesae progression/replase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'alternative therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'never start protocol therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was activated on October 15, 2003. Accrual was suspended on November 26, 2004 and subsequently closed on October 25, 2005 with total accrual of 225 patients to step 1 and 179 patients to step 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Irinocetan (Arm I)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received irinocetan plus 5-FU and leucovorin,'}, {'id': 'BG001', 'title': 'Oxaliplatin (Arm II)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received oxaliplatin plus 5-FU and leucovorin.'}, {'id': 'BG002', 'title': 'Control (Arm III)', 'description': 'The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group only received 5-FU and leucovorin.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '82'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '79'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '36', 'upperLimit': '79'}, {'value': '57', 'groupId': 'BG003', 'lowerLimit': '33', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized patients in Step 2'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2008-06-26', 'size': 1168328, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-06-06T09:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10-15'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-03', 'studyFirstSubmitDate': '2003-09-10', 'resultsFirstSubmitDate': '2018-06-18', 'studyFirstSubmitQcDate': '2003-09-10', 'lastUpdatePostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-03', 'studyFirstPostDateStruct': {'date': '2003-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year Overall Survival Rate', 'timeFrame': 'assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 years', 'description': 'Overall survival (OS) was defined as time from randomization to death from any cause. 3-year OS rate was estimated using Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': '3-year Disease Free Survival', 'timeFrame': 'assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 years', 'description': 'Disease free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer and death from any cause, whichever occurred first. 3-year DFS rate was estimated using Kaplan-Meier method.'}, {'measure': 'Proportion of Sphincter Preservation', 'timeFrame': 'assessed at primary surgery time', 'description': 'Proportion of sphincter preservation was defined as number of patients with sphincter preservation divided by total number of patients randomized to the arm'}, {'measure': 'Failure Pattern', 'timeFrame': 'assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years', 'description': 'Type of failures (local/regional recurrence vs. distant recurrence vs. concurrent recurrence vs. second primary cancer vs. deaths) in the analysis population'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rectal cancer', 'chemotherapy', 'irinotecan', 'oxaliplatin'], 'conditions': ['Rectal Mucinous Adenocarcinoma', 'Rectal Signet Ring Cell Adenocarcinoma', 'Recurrent Rectal Carcinoma', 'Stage IIA Rectal Cancer AJCC v7', 'Stage IIB Rectal Cancer AJCC v7', 'Stage IIC Rectal Cancer AJCC v7', 'Stage IIIA Rectal Cancer AJCC v7', 'Stage IIIB Rectal Cancer AJCC v7', 'Stage IIIC Rectal Cancer AJCC v7', 'Stage IVA Rectal Cancer AJCC v7', 'Stage IVB Rectal Cancer AJCC v7']}, 'referencesModule': {'references': [{'pmid': '41397917', 'type': 'DERIVED', 'citation': "Kam AE, Zhao F, Meropol NJ, Giantonio BJ, Diasio RB, Flynn PJ, Catalano P, Hartner L, Rowland KM, Song W, Mulcahy MF, Sinicrope FA, Whitehead RP, Mayer RJ, Petrelli N, O'Dwyer PJ, Hamilton SR, Cella D, Benson AB 3rd. Intergroup Randomized Phase III Study of Adjuvant FOLFIRI, FOLFOX, or 5-FU/Leucovorin for Stage II/III Rectal Cancer: ECOG-ACRIN E3201. Oncologist. 2025 Dec 15:oyaf416. doi: 10.1093/oncolo/oyaf416. Online ahead of print."}]}, 'descriptionModule': {'briefSummary': 'This randomized phase III trial is comparing the effectiveness of three adjuvant combination chemotherapy regimens in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for stage II or stage III rectal cancer. Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which adjuvant combination chemotherapy regimen is more effective in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for rectal cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To compare the overall survival of patients treated with irinotecan, 5-FU and leucovorin versus those treated with oxaliplatin, leucovorin and 5-FU versus those treated with leucovorin and 5-FU for patients with stage II and III rectal cancer.\n\nSECONDARY OBJECTIVES:\n\nI. To determine sphincter preservation, tolerance of treatment and patterns of failure.\n\nII. To describe patterns of failures\n\nOTHER PRE-SPECIFIED OBJECTIVES:\n\nI.To prospectively assess rectal function using the Patient Bowel Function/Uniscale questionnaire and the FACT Diarrhea Subscale in patients treated with an adjuvant program of pelvic radiation therapy and chemotherapy.\n\nII. To correlate expression of key targets for 5-FU, leucovorin, oxaliplatin and irinotecan from tumor tissue biopsies with treatment efficacy III. To correlate tumor molecular prognostic markers with survival. IV. To determine physician preference in regard to the radiation-chemotherapy sequence in the Intergroup.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1), chemotherapy/radiotherapy sequence (preoperative vs postoperative), and risk group (high risk \\[T3, N+, M0 or T4, any N, M0\\] vs low risk \\[T1-2, N+, M0 or T3, N0, M0\\]). Patients are treated in 1 of 2 groups according to physician preference and then randomized to 1 of 3 treatment arms.\n\nGROUP I (preoperative chemoradiotherapy and additional adjuvant chemotherapy): Preoperative chemoradiotherapy: Patients receive 1 of 3 treatment regimens, determined by the treating physician.\n\nREGIMEN A (radiotherapy and fluorouracil): Patients undergo external beam radiotherapy once daily 5 days a week for 5 1/2 weeks (total of 28 fractions). Patients also receive concurrent fluorouracil intravenously (IV) continuously 7 days a week for 5 1/2 weeks.\n\nREGIMEN B (radiotherapy, fluorouracil, and leucovorin calcium): Patients undergo external beam radiotherapy as in regimen A. Patients also receive concurrent fluorouracil IV and leucovorin calcium IV continuously for 4 days on weeks 1 and 5.\n\nREGIMEN C (radiotherapy and capecitabine)\\*: Patients undergo external beam radiotherapy as in regimen A. Patients also receive concurrent oral capecitabine twice daily for 5 1/2 weeks.\n\nNOTE: \\*Regimen C is allowed only for patients enrolled on protocol NSABP-R-04.\n\nSurgery: Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection.\n\nAdditional adjuvant chemotherapy: Within 21-56 days after complete surgical resection, patients are randomized to 1 of 3 treatment arms.\n\nARM I: Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses.\n\nARM II: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses.\n\nARM III: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses.\n\nIn all arms, treatment continues in the absence of disease progression or unacceptable toxicity.\n\nGROUP 2 (postoperative chemoradiotherapy and additional adjuvant chemotherapy): Within 21-56 days after complete surgical resection, patients are randomized to 1 of 3 treatment arms.\n\nARM I: Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses.\n\nARM II: Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses.\n\nARM III: Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course.\n\nWithin 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemoradiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.\n\nTreatment continues in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Group I (Pre-operative) Registration\n\n Inclusion Criteria:\n * Patients must have histologically proven adenocarcinoma of the rectum with no distant metastases. Clinical staging is required (T3N0M0, T4N0M0, TanyN1-3M0).\n * Patients must not have evidence of tumor outside of the pelvis including liver metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy.\n * The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 cm of anal verge by proctoscopic examination. In addition, patients who have had a portion of their tumors confirmed to be below the peritoneal reflection at the time of surgery are eligible regardless of the distance determined by endoscopy.\n * Transmural penetration of tumor through the muscularis propria must be demonstrated by CT scan, endo-rectal ultrasound or MRI.\n * Tumors must be defined prospectively by the surgeon as clinically resectable or not.\n\n * Clinically resectable tumors will be defined by the surgeon as not fixed and completely resectable with negative margins based on the routine examination of the non-anesthetized patient.\n * Before pre-op treatment, the surgeon should estimate and record the type of resection anticipated: APR, LAR or LAR/coloanal anastomosis.\n * The tumor may be clinically fixed or initially not completely resectable, clinical stage T4 N0-2 M0 based on the presence of at least one of the following criteria:\n\n * Clinically fixed tumors on rectal examination with tumor adherent to the pelvic sidewall or sacrum.\n * Hydronephrosis on CT scan or IVP or ureteric or bladder invasion as documented by cystoscopy and cytology or biopsy, or invasion into prostate.\n * Vaginal or uterine involvement.\n * Patients must not have a previous or concurrent malignancy, with the exception of:\n\n * Nonmelanoma skin cancer or in situ cervical cancer.\n * Treated non-pelvic cancer from which the patient has been continuously disease-free for \\>5 years.\n * Patients must have ECOG performance status 0-1.\n * Patients must be \\> 18 years of age.\n * All females of childbearing potential must have a blood or urine test within 2 weeks prior to registration to rule out pregnancy.\n * Sexually-active women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception\n\n Exclusion Criteria:\n * Patients have received prior chemotherapy or pelvic irradiation therapy.\n * Female patients must not be pregnant or breast-feeding.\n * Patients have an active inflammatory bowel disease or other serious medical illness which might limit the ability of the patient to receive protocol therapy.\n2. Group II (Post-operative) Registration\n\n Inclusion Criteria:\n * Patients must have had histologically proven adenocarcinoma of the rectum with no distant metastases. Pathologic staging is required (T3N0M0, T4N0M0, TanyN1-3M0).\n * Patients must not have evidence of tumor outside of the pelvis including liver metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy.\n * The distal border of the tumor must have been at or below the peritoneal reflection, defined as within 12 centimeters of anal verge by proctoscopic examination. In addition, patients who have had a portion of their tumors confirmed to be below the peritoneal reflection at the time of the surgery are eligible regardless of the distance determined by endoscopy.\n * Patients must not have received prior chemotherapy or pelvic irradiation therapy.\n * Patients must not have a previous or concurrent malignancy, with the exception of:\n\n * Non-melanoma skin cancer or in situ cervical cancer.\n * Treated non-pelvic cancer from which the patient has been continuously disease-free for \\>5 years.\n * Patients must have ECOG performance status 0-1.\n * Patients must be \\> 18 years of age.\n * All females of childbearing potential must have a blood or urine test within 2 weeks prior to registration to rule out pregnancy.\n * Sexually active women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.\n\n Exclusion Criteria:\n * Patients have an active inflammatory bowel disease or other serious medical illness which might limit the ability of the patient to receive protocol therapy.\n * Female patients are pregnant or breast-feeding.\n3. Randomization (Groups I and II)\n\nInclusion Criteria:\n\n* Patients must have a completely resected tumor and be within 21-56 days from the date of surgery.\n* Patients who received combination chemotherapy/XRT prior to randomization (Group I) must have had a minimum radiation dose of 50.4 Gy.\n* Patients must have ECOG performance status 0-1.\n* Patients must have adequate renal function (creatinine \\< 1.5 x ULN) obtained \\< 4 weeks prior to randomization.\n* Patients must have adequate hepatic function (bilirubin \\< 1.5 x ULN, SGOT (AST) \\< 3 x ULN) obtained \\< 4 weeks prior to randomization).\n* Patients must have absolute neutrophil count \\> 1500/mm3 and platelet count \\> 100,000/mm3 \\< 4 weeks prior to randomization.\n\nExclusion Criteria:\n\n• Patients have an active inflammatory bowel disease or other serious medical illness which might limit the ability of the patient to receive protocol therapy.'}, 'identificationModule': {'nctId': 'NCT00068692', 'briefTitle': 'Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Intergroup Randomized Phase III Study of Postoperative Irinotecan, 5-Fluorouracil and Leucovorin vs. Oxaliplatin, 5-Fluorouracil and Leucovorin vs. 5-Fluorouracil and Leucovorin for Patients With Stage II or III Rectal Cancer Receiving Either Preoperative Radiation and 5-Fluorouracil or Postoperative Radiation and 5-Fluorouracil', 'orgStudyIdInfo': {'id': 'NCI-2012-02959'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02959', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'E3201', 'type': 'OTHER', 'domain': 'ECOG-ACRIN Cancer Research Group'}, {'id': 'U10CA021115', 'link': 'https://reporter.nih.gov/quickSearch/U10CA021115', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I, Arm I', 'description': 'Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Radiation: Radiotherapy', 'Drug: Fluorouracil', 'Drug: Leucovorin Calcium', 'Drug: Irinotecan']}, {'type': 'EXPERIMENTAL', 'label': 'Group I, Arm II', 'description': 'Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Radiation: Radiotherapy', 'Drug: Fluorouracil', 'Drug: Leucovorin Calcium', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Group I, Arm III', 'description': 'Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Radiation: Radiotherapy', 'Drug: Fluorouracil', 'Drug: Leucovorin Calcium']}, {'type': 'EXPERIMENTAL', 'label': 'Group II, Arm I', 'description': 'Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.\n\nTreatment continues in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Radiation: Radiotherapy', 'Drug: Fluorouracil', 'Drug: Leucovorin Calcium', 'Drug: Irinotecan']}, {'type': 'EXPERIMENTAL', 'label': 'Group II, Arm II', 'description': 'Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.\n\nTreatment continues in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Radiation: Radiotherapy', 'Drug: Fluorouracil', 'Drug: Leucovorin Calcium', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Group II, Arm III', 'description': 'Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Radiation: Radiotherapy', 'Drug: Fluorouracil', 'Drug: Leucovorin Calcium']}], 'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'otherNames': ['Definitive Radiation Therapy', 'EBRT', 'External Beam Radiotherapy', 'external radiation'], 'description': 'Undergo external beam radiation therapy', 'armGroupLabels': ['Group I, Arm I', 'Group I, Arm II', 'Group I, Arm III', 'Group II, Arm I', 'Group II, Arm II', 'Group II, Arm III']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'otherNames': ['Efudex', '5-FU', '5-Fluorouracil', 'Adrucil'], 'description': 'Given IV', 'armGroupLabels': ['Group I, Arm I', 'Group I, Arm II', 'Group I, Arm III', 'Group II, Arm I', 'Group II, Arm II', 'Group II, Arm III']}, {'name': 'Leucovorin Calcium', 'type': 'DRUG', 'otherNames': ['Leucovorin', 'Wellcovorin', 'citrovorun factor', 'folinic acid', 'LV', 'LCV', '5-formyl tetrahydrofolate'], 'description': 'Given IV', 'armGroupLabels': ['Group I, Arm I', 'Group I, Arm II', 'Group I, Arm III', 'Group II, Arm I', 'Group II, Arm II', 'Group II, Arm III']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['1-OHP', 'Dacplat', 'Eloxatin', 'Eloxatine', 'Trans-l-diaminocyclohexane oxalatoplatinum', 'Cis-[oxalato (trans-I-1 ,2-diaminocyclohexane) platinum(lI)]', "cis -[(1R,2R)-1,2-cyclohexanediamine- N,N'] [oxalate(2-)- 0,0'] platinum"], 'description': 'Given IV', 'armGroupLabels': ['Group I, Arm II', 'Group II, Arm II']}, {'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['Camptosar', 'CPT-11', 'Camptothecin-11'], 'description': 'Given IV', 'armGroupLabels': ['Group I, Arm I', 'Group II, Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Eastern Cooperative Oncology Group', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Al Benson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Cooperative Oncology Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Individual patient data will be shared upon approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}