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| Descriptive Information Fields | |||||||||||||||||||||||||
| Brief Title † | Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer | ||||||||||||||||||||||||
| Official Title † | A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum | ||||||||||||||||||||||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior adjuvant chemotherapy (yes vs no), prior immunotherapy (yes vs no), and age (under 65 vs 65 and over). Patients are randomized to one of three treatment arms. Only arm II remains open to accrual.
Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 825 patients (275 per arm) have been accrued for this study thus far. Additional patients are being accrued on arm II. (Arms I and III closed to accrual as of March 15, 2002.) |
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| Study Phase | Phase III | ||||||||||||||||||||||||
| Study Type † | Interventional | ||||||||||||||||||||||||
| Study Design † | Treatment, Randomized, Active Control | ||||||||||||||||||||||||
| Primary Outcome Measure † | |||||||||||||||||||||||||
| Secondary Outcome Measure † | |||||||||||||||||||||||||
| Condition † | Colorectal Cancer | ||||||||||||||||||||||||
| Intervention † | Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin |
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| MEDLINE PMIDs | 17687151, 16849748, 15677624, 15470715, 14665611, 18182660, 11204663 | ||||||||||||||||||||||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||||||||||||||||||||||
| Recruitment Status † | Completed | ||||||||||||||||||||||||
| Enrollment † | |||||||||||||||||||||||||
| Start Date † | October 1998 | ||||||||||||||||||||||||
| Completion Date | |||||||||||||||||||||||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
| Contacts †† | |||||||||||||||||||||||||
| Location Countries † | United States, Canada, Puerto Rico, South Africa | ||||||||||||||||||||||||
| Administrative Information Fields | |||||||||||||||||||||||||
| NCT ID † | NCT00003594 | ||||||||||||||||||||||||
| Organization ID | CDR0000066665 | ||||||||||||||||||||||||
| Secondary IDs †† | NCCTG-N9741, CAN-NCIC-CO13, CLB-89804, E-N9741, SWOG-N9741 | ||||||||||||||||||||||||
| Study Sponsor † | North Central Cancer Treatment Group | ||||||||||||||||||||||||
| Collaborators †† | National Cancer Institute (NCI) Cancer and Leukemia Group B National Cancer Institute of Canada Eastern Cooperative Oncology Group Southwest Oncology Group |
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| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||||||||||
| Verification Date | June 2008 | ||||||||||||||||||||||||
| First Received Date † | November 1, 1999 | ||||||||||||||||||||||||
| Last Updated Date | July 23, 2008 | ||||||||||||||||||||||||