Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 4:50 PM
Study NCT ID:
NCT00070434
Status:
WITHDRAWN
Last Update Posted:
2012-06-07
First Post:
2003-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S0304 Induct Chemo Then Chemo-RT in Pts w/Locally Advanced Adenocarcinoma of the Rectum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal 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': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011736', 'term': 'Pyridoxine'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'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': 'D013812', 'term': 'Therapeutics'}, {'id': 'D025101', 'term': 'Vitamin B 6'}, {'id': 'D010847', 'term': 'Picolines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'poor accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-05', 'studyFirstSubmitDate': '2003-10-03', 'studyFirstSubmitQcDate': '2003-10-06', 'lastUpdatePostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response (confirmed and unconfirmed response, complete response, partial response)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage II rectal cancer', 'stage III rectal cancer', 'adenocarcinoma of the rectum'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, fluorouracil, 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. Combining radiation therapy with chemotherapy may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well different regimens of induction chemotherapy followed by chemoradiotherapy work in treating patients with locally advanced adenocarcinoma of the rectum.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the feasibility of obtaining a pre-treatment determination of intratumoral molecular markers (TS, DPD, and ERCC-1) for use in selection of the appropriate regimen for induction cytotoxic combination chemotherapy in patients with cT3-4 rectal adenocarcinoma.\n* Determine the response probability (unconfirmed, complete and partial) in patients treated with targeted induction cytotoxic chemotherapy.\n* Determine the toxicity of targeted induction cytotoxic chemotherapy and chemoradiotherapy in these patients.\n* Determine the response probability in these patients treated with chemoradiotherapy.\n\nOUTLINE: This is a multicenter study.\n\n* Induction chemotherapy: Patients are assigned to 1 of 3 treatment groups based on molecular analysis of the pretreatment tumor specimen.\n\n * Group I (lower likelihood of resistance to a fluorouracil-based regimen): Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1.\n * Group II (higher likelihood of resistance to a fluorouracil-based regimen): Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on day 1.\n * Group III (high likelihood of sensitivity to oxaliplatin and fluorouracil therapy): Patients receive oxaliplatin IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1.\n\nTreatment in all groups repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are evaluated for response approximately 2 weeks after the completion of induction chemotherapy. Patients with stable disease or better receive chemoradiotherapy.\n\n* Chemoradiotherapy: Beginning approximately 3 weeks after the completion of induction chemotherapy, patients receive oral capecitabine twice daily continuously for 5 weeks and concurrent radiotherapy once daily 5 days a week for 5 weeks.\n\nAfter chemoradiotherapy, patients may undergo attempted surgical resection at the discretion of the treating physician.\n\nPatients are followed every 3 months for 1 year and then every 6 months for 2 years.\n\nPROJECTED ACCRUAL: A total of 10-65 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary adenocarcinoma of the rectum\n* Locally advanced disease (clinical T3-4, N0-2, M0) based on at least 1 of the following criteria:\n\n * Clinically fixed tumors on rectal examination with tumor adherent to the pelvic sidewall and/or sacrum\n * Sciatica attributed to sacral root invasion with CT scan/MRI evidence of the lack of clear tissue plane is considered evidence of fixation\n * Hydronephrosis on CT scan or intravenous pyelogram of ureteric or bladder invasion by cystoscopy and cytology or biopsy\n * Invasion into the prostate, vagina, or uterus\n* Transmural penetration of tumor through the muscularis propria as evidenced by CT scan or MRI and endorectal ultrasound\n* Distal border of the tumor must be at or below the peritoneal reflection (within 12 cm of the anal verge) by proctoscopic examination\n* Measurable disease by x-ray, scans, or physical examination\n* Available tumor tissue to determine molecular profile of the tumor before study treatment\n* No clinical evidence of high-grade (lumen diameter \\< 1 cm) large bowel obstruction unless a diverting colostomy has been performed\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Zubrod 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC ≥ 3,500/mm\\^3\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥100,000/mm\\^3\n\nHepatic\n\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* SGOT or SGPT ≤ 2.5 times ULN\n* Alkaline phosphatase ≤ 2.5 times ULN\n\nRenal\n\n* See Disease Characteristics\n* Creatinine ≤ 1.5 times ULN OR\n* Estimated creatinine clearance \\> 50 mL/min\n\nCardiovascular\n\n* No significant cardiac disease\n* No recent myocardial infarction\n\nGastrointestinal\n\n* See Disease Characteristics\n* Able to swallow oral medication\n* No active inflammatory bowel disease\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n* No prior unanticipated severe reaction to study drugs\n* No known dihydropyrimidine dehydrogenase deficiency\n* No serious uncontrolled infection\n* No other serious medical illness that would preclude study treatment\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy for colon or rectal cancer\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior pelvic radiotherapy\n* No prior intra-operative radiotherapy or brachytherapy\n* No concurrent intra-operative radiotherapy or brachytherapy\n* No concurrent intensity-modulated radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n* See Radiotherapy'}, 'identificationModule': {'nctId': 'NCT00070434', 'briefTitle': 'S0304 Induct Chemo Then Chemo-RT in Pts w/Locally Advanced Adenocarcinoma of the Rectum', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'A Phase II Feasibility Translational Research Trial of Induction Chemotherapy Followed by Concomitant Chemoradiation in Patients With Clinical T4 Rectal Cancer', 'orgStudyIdInfo': {'id': 'CDR0000334469'}, 'secondaryIdInfos': [{'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}, {'id': 'S0304', 'type': 'OTHER', 'domain': 'SWOG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Irinotecan + 5-FU + Leucovorin', 'description': 'Irinotecan 180mg/m2, IV for 90min on Day 1, q 2 wk x 4 cycles; 5-FU 400 mg/m2, IV bolus on Day 1, q 2 wk x 4 cycles; 5-FU 2.4 g/m2 IV for 46 hours on Day 1, q 2 wk x 4 cycles; Leucovorin 200 mg/m2 IV for 2 hours on Day 1, q 2 wk x4 cycles.', 'interventionNames': ['Drug: capecitabine', 'Drug: fluorouracil', 'Drug: irinotecan hydrochloride', 'Drug: leucovorin calcium', 'Radiation: radiation therapy', 'Drug: Pyridoxine']}, {'type': 'EXPERIMENTAL', 'label': 'Irinotecan + Oxaliplatin', 'description': 'Irinotecan 175mg/m2 IV for 90 minutes on Day 1, q 2wk x4 cycles; Oxaliplatin 85mg/m2 IV for 2 hours on Day 1, q 2wk x4 cycles', 'interventionNames': ['Drug: capecitabine', 'Drug: irinotecan hydrochloride', 'Drug: oxaliplatin', 'Radiation: radiation therapy', 'Drug: Pyridoxine']}, {'type': 'EXPERIMENTAL', 'label': 'Oxaliplatin + 5-FU + Leucovorin', 'description': 'Oxaliplatin 85mg/m2 IV for 90 minutes on Day 1, q 2wk x4 cycles; 5-FU 400mg/m2 IV bolus on Day 1, q 2wk x4 cycles; 5-FU 2.4g/m2 IV for 46 hours on Day 1, q 2wk x4 cycles; Leucovorin 200mg/m2 IV for 2 hours on Day 1, q 2wk x4 cycles.', 'interventionNames': ['Drug: capecitabine', 'Drug: fluorouracil', 'Drug: leucovorin calcium', 'Drug: oxaliplatin', 'Radiation: radiation therapy', 'Drug: Pyridoxine']}], 'interventions': [{'name': 'capecitabine', 'type': 'DRUG', 'description': '825mg/m2 BID, PO, daily', 'armGroupLabels': ['Irinotecan + 5-FU + Leucovorin', 'Irinotecan + Oxaliplatin', 'Oxaliplatin + 5-FU + Leucovorin']}, {'name': 'fluorouracil', 'type': 'DRUG', 'description': 'Bolus + IV for 46 hrs on Day 1', 'armGroupLabels': ['Irinotecan + 5-FU + Leucovorin', 'Oxaliplatin + 5-FU + Leucovorin']}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'description': 'IV infusion over 90 min on Day 1', 'armGroupLabels': ['Irinotecan + 5-FU + Leucovorin', 'Irinotecan + Oxaliplatin']}, {'name': 'leucovorin calcium', 'type': 'DRUG', 'description': '200mg/m2 IV 2 hour infusion on Day 1', 'armGroupLabels': ['Irinotecan + 5-FU + Leucovorin', 'Oxaliplatin + 5-FU + Leucovorin']}, {'name': 'oxaliplatin', 'type': 'DRUG', 'description': '85mg/m2 IV infusion for 90minutes on Day 1', 'armGroupLabels': ['Irinotecan + Oxaliplatin', 'Oxaliplatin + 5-FU + Leucovorin']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'Original Planning Target Volume (PTV1): The total dose to the prescription point shall be 4500 cGy in 25 fractions (Monday - Friday inclusive). Boost Planning Target Volume (PTV2): The cumulative dose within the boost volume to the prescription point shall be 5,040 - 5,400 cGy (per Section 7.5b). Daily Dose: The daily dose to the prescription point of the original and boost volumes shall be 180 cGy. Fractionation: Treatment shall be given 5 days/week. All radiation fields shall be treated once daily.', 'armGroupLabels': ['Irinotecan + 5-FU + Leucovorin', 'Irinotecan + Oxaliplatin', 'Oxaliplatin + 5-FU + Leucovorin']}, {'name': 'Pyridoxine', 'type': 'DRUG', 'description': '50mg TID, PO daily', 'armGroupLabels': ['Irinotecan + 5-FU + Leucovorin', 'Irinotecan + Oxaliplatin', 'Oxaliplatin + 5-FU + Leucovorin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Charles R. Thomas, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}, {'name': 'Heinz-Josef Lenz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Southern California'}, {'name': 'Robert P. Whitehead, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Texas'}, {'name': 'James L. Abbruzzese, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D. Anderson Cancer Center'}, {'name': 'Stephen R. Smalley, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Radiation Oncology Center of Olathe'}, {'name': 'Morton S. Kahlenberg, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}