Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT00268333
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2005-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'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': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2009-02-06', 'studyFirstSubmitDate': '2005-12-20', 'studyFirstSubmitQcDate': '2005-12-20', 'lastUpdatePostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate'}], 'secondaryOutcomes': [{'measure': 'Overall survival'}, {'measure': 'Disease-free survival'}, {'measure': 'Primary site of recurrence'}, {'measure': 'Time to recurrence'}, {'measure': 'Quality of life'}]}, 'conditionsModule': {'keywords': ['adenocarcinoma of the colon', 'adenocarcinoma of the rectum', 'stage IV colon cancer', 'stage III colon cancer', 'stage III rectal cancer', 'stage IV rectal cancer'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with recurrent metastatic colorectal cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the response rate in patients with recurrent metastatic colorectal cancer treated with neoadjuvant oxaliplatin, fluorouracil, and leucovorin calcium followed by radiotherapy and concurrent fluorouracil and oxaliplatin.\n\nSecondary\n\n* Determine the overall survival and disease-free survival of patients treated with this regimen.\n* Determine the primary site of recurrence and time to recurrence in patients treated with this regimen.\n* Determine quality of life of patients treated with this regimen.\n\nOUTLINE: This is a nonrandomized, open-label, multicenter study.\n\n* Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Two to 5 weeks later, patients with stable or responding disease proceed to chemoradiotherapy.\n* Chemoradiotherapy: Patients receive fluorouracil IV continuously 5 days a week for 5 weeks and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29. Patients also undergo radiotherapy 5 days a week for 5 weeks beginning on day 1.\n\nQuality of life is assessed at baseline, 1 week after the completion of neoadjuvant chemotherapy, on days 15, 30, and 42 of chemoradiotherapy, and at 1 and 2 months after the completion of study treatment.\n\nAfter completion of study treatment, patients are followed periodically.\n\nPROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the colon or rectum\n\n * Metastatic disease isolated to the following lymph nodes:\n\n * Aortic\n * Interaortic\n * Celiomesenteric\n * Retroperitoneal, including the following sites:\n\n * Peri-uretal\n * Liver\n * Iliac\n * Clavicle\n * Mediastinum\n * Inguinal\n * Cervical\n* Incompletely resected disease\n* Recurrent disease, defined by 1 of the following criteria:\n\n * Progression occurred within 6 months after prior oxaliplatin or after the patient received no prior oxaliplatin\n * Progressive disease after cisplatin or fluorouracil\n* Must be able to be encompassed in radiation field\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%\n* Life expectancy more than 12 weeks\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000 /mm\\^3\n* Alkaline phosphatase ≤ 5 times normal\n* Bilirubin ≤ 2 times normal\n* Creatinine \\< 2 times normal or creatinine clearance ≥ 40 mL/min\n* No peripheral neuropathy \\> grade 1\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No weight loss \\> 15% since diagnosis of recurrent disease\n* No uncontrolled heart disease\n* No angina\n* No symptomatic disease of the inferior artery\n* No psychological, familial, sociological, or geographical condition that would preclude study treatment or compliance\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior chemotherapy or radiotherapy\n* No concurrent corticosteroids'}, 'identificationModule': {'nctId': 'NCT00268333', 'briefTitle': 'Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Study of Recurrent Ganglionic Colorectal Cancer Not Accessible By Surgery Treated Using Chemotherapy With Simplified FOLFOX7 Followed By Radiotherapy Combined With 5FU and Oxaliplatin', 'orgStudyIdInfo': {'id': 'CDR0000453784'}, 'secondaryIdInfos': [{'id': 'GERCOR-C04-1'}, {'id': 'EU-20568'}, {'id': 'SANOFI-GERCOR-C04-1'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'leucovorin calcium', 'type': 'DRUG'}, {'name': 'oxaliplatin', 'type': 'DRUG'}, {'name': 'neoadjuvant therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84082', 'city': 'Avignon', 'country': 'France', 'facility': 'Institut Sainte Catherine', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Hopital Drevon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '33500', 'city': 'Libourne', 'country': 'France', 'facility': 'Hopital Robert Boulin', 'geoPoint': {'lat': 44.91449, 'lon': -0.24186}}, {'zip': '33310', 'city': 'Lormont', 'country': 'France', 'facility': 'Polyclinique des Quatre Pavillons', 'geoPoint': {'lat': 44.8765, 'lon': -0.51919}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Europeen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'F-51100', 'city': 'Reims', 'country': 'France', 'facility': 'Polyclinique De Courlancy', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '60309', 'city': 'Senlis', 'country': 'France', 'facility': 'C.H. Senlis', 'geoPoint': {'lat': 49.20724, 'lon': 2.58661}}], 'overallOfficials': [{'name': 'Laurent Mineur, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut Sainte Catherine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GERCOR - Multidisciplinary Oncology Cooperative Group', 'class': 'OTHER'}}}}