Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 12:18 AM
Study NCT ID:
NCT00006094
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2000-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, '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': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-15', 'studyFirstSubmitDate': '2000-08-03', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The maximum tolerated dose of oxaliplatin when delivered concurrently with 5-FU and external beam radiation in patients with locally advanced rectal adenocarcinomas', 'timeFrame': '7 days'}, {'measure': 'Progression-free survival', 'timeFrame': 'From protocol entry until documented progression of disease or death from any cause, assessed up to 5 years', 'description': 'Will be estimated using the Kaplan-Meier method.'}, {'measure': 'Pathological complete response rate', 'timeFrame': 'Up to 5 years', 'description': "The new regimen will be considered worthy of further investigation if 5 or greater CR's are observed among the 25 patients treated at the MTD. Assuming the new regimen will result in a 30% CR rate, the probability of observing 5 or greater CR's in 25 patients studied is 0.91. For an underlying CR rate of 0.25 this probability is 0.79. The probability of observing 5 or greater CR's if the underlying CR rate is 0.10 is 0.10."}, {'measure': 'Latent toxicities graded using the Common Toxicity Criteria (CTC) version 2.0', 'timeFrame': 'Up to 5 years'}]}, 'conditionsModule': {'conditions': ['Adenocarcinoma of the Rectum', 'Stage II Rectal Cancer', 'Stage III Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'Drugs used in chemotherapy 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 chemotherapy, radiation therapy, and surgery may be a more effective treatment for cancer of the rectum. Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil, and external-beam radiation therapy followed by surgery in treating patients who have locally advanced cancer of the rectum', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine the maximum tolerated dose of oxaliplatin when combined with fluorouracil and external beam radiotherapy in patients with locally advanced adenocarcinoma of the rectum.\n\n(Phase I closed to accrual effective 03/27/2003). II. Determine the pathological response rate in patients treated with this preoperative regimen and surgical resection.\n\nIII.Determine the late toxicity of this preoperative regimen in these patients. IV. Determine, in a preliminary manner, the progression-free survival, local control, and overall survival in patients treated with this regimen.\n\nOUTLINE: This is a dose-escalation, multicenter study of oxaliplatin.\n\nPatients receive oxaliplatin IV over 1 hour on day 1, fluorouracil IV continuously on days 1-7, and radiotherapy on days 1-5. Treatment repeats weekly for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level in the phase II portion of the study. (Phase I closed to accrual effective 03/27/2003). Patients may undergo radical resection of rectal tumor within 4-6 weeks after completion of chemoradiotherapy.\n\nPatients are followed every 3 months for 2 years and then every 6 months for 3 years.\n\nPROJECTED ACCRUAL: A total of 9-24 patients will be accrued for phase I of the study (phase I closed to accrual effective 03/27/2003) and a total of 19 patients will be accrued for phase II of the study within 12-18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven previously untreated adenocarcinoma of the rectum thatbegins within 12 cm of the anal verge by sigmoidoscopy and/or colonoscopy\n\n * Locally advanced disease defined as any of the following:\n\n * Fixed or immovable tumor on physical exam\n * T4 disease with invasion of adjacent structures (e.g., pelvic sidewall, sacral pelvis, bladder, or prostate) by CT scan, rectal ultrasound, or MRI\n * T3 disease with invasion through the wall of the muscularis propria by transrectal ultrasound, CT scan, or MRI\n* No distant metastatic disease\n* Performance status - ECOG 0-2\n* Granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Bilirubin no greater than upper limit of normal (ULN)\n* SGOT/SGPT no greater than 2.5 times ULN\n* Creatinine no greater than 1.5 mg/dL\n* Creatinine clearance at least 60 mL/min\n* No active second malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix\n* Patients are not considered to have an active second malignancy if they have completed therapy and are at less than 30% risk of relapse\n* No prior or concurrent evidence of neuropathy\n* No history of allergy to platinum compounds or antiemetics\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No prior fluorouracil or platinum-based therapy for any malignancy\n* No other concurrent chemotherapy\n* Hormonal therapy allowed only for non-disease related conditions (e.g., insulin for diabetes) OR intermittently as an antiemetic (e.g., dexamethasone)\n* No prior pelvic irradiation\n* No concurrent antiretroviral therapy (HAART) for HIV positive patients'}, 'identificationModule': {'nctId': 'NCT00006094', 'briefTitle': 'Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I/II Study of Preoperative Oxaliplatin (NSC# 266046), 5-Fluorouracil, and External Beam Radiation Therapy in Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': 'NCI-2012-02357'}, 'secondaryIdInfos': [{'id': 'CALGB-89901'}, {'id': 'U10CA031946', 'link': 'https://reporter.nih.gov/quickSearch/U10CA031946', 'type': 'NIH'}, {'id': 'CDR0000068099', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (oxaliplatin, fluorouracil, EBRT)', 'description': 'Patients receive oxaliplatin IV over 1 hour on day 1, fluorouracil IV continuously on days 1-7, and radiotherapy on days 1-5. Treatment repeats weekly for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: oxaliplatin', 'Drug: fluorouracil', 'Radiation: external beam radiation therapy']}], 'interventions': [{'name': 'oxaliplatin', 'type': 'DRUG', 'otherNames': ['1-OHP', 'Dacotin', 'Dacplat', 'Eloxatin', 'L-OHP'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (oxaliplatin, fluorouracil, EBRT)']}, {'name': 'fluorouracil', 'type': 'DRUG', 'otherNames': ['5-fluorouracil', '5-Fluracil', '5-FU'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (oxaliplatin, fluorouracil, EBRT)']}, {'name': 'external beam radiation therapy', 'type': 'RADIATION', 'otherNames': ['EBRT'], 'description': 'Undergo external beam radiation therapy', 'armGroupLabels': ['Treatment (oxaliplatin, fluorouracil, EBRT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60606', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cancer and Leukemia Group B', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'David Ryan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer and Leukemia Group B'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}