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Phase III Randomized Study of Adjuvant Chronomodulated Versus Standard Schedule Fluorouracil and Leucovorin Calcium With or Without Carboplatin in Patients With Completely Resected Stage IIB or III Colon Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Combination Chemotherapy in Treating Patients With Colon Cancer
Basic Trial Information
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Phase III
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Active
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18 and over
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GRECCR-03
EU-20201, NCT00046995
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Objectives - Compare the disease-free survival of patients with completely resected stage IIB or III colon cancer treated with adjuvant chronomodulated vs standard schedule fluorouracil and leucovorin calcium with or without carboplatin.
- Compare the overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Determine the dose intensities of fluorouracil and carboplatin in these patients.
Entry Criteria Disease Characteristics:
- Histologically confirmed adenocarcinoma of the colon
- Stage IIB or III (Dukes stage B2 or C)
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Complete curative resection performed within the past 7 weeks (negative
margins)
- No local or regional relapsed disease
- Tumor more than 15 cm above the anal margin
- Carcinoembryonic antigen less than 5 ng/mL (after surgery)
- No rectal cancer
- No metastatic disease
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy Radiotherapy - No prior radiotherapy (before or after surgery)
Surgery - See Disease Characteristics
Other - No concurrent participation in another clinical trial
Patient Characteristics:
Age Performance status - ECOG 0-1
OR -
Karnofsky 60-100%
Life expectancy Hematopoietic - Neutrophil count at least 2,000/mm3
- Platelet count at least 100,000/mm3
Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT and SGPT no greater than 5 times ULN
Renal - Creatinine no greater than 1.5 times ULN
Cardiovascular - No serious coronary disease
Other - Not pregnant
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Fertile patients must use effective contraception
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No concurrent infectious disease
- No other malignancy except adequately treated basal cell skin cancer or
carcinoma in situ of the cervix
Expected Enrollment 800A total of 660-800 patients will be accrued for this study. Outcomes Primary Outcome(s)Disease-free survival
Secondary Outcome(s)Tolerability
Quality of life
Outline This is a randomized, multicenter study. Patients are stratified according to participating center and disease stage (IIB vs III). Patients are randomized to 1 of 4 treatment arms. - Arm I (standard schedule): Patients receive fluorouracil (5-FU) IV continuously and leucovorin calcium (CF) IV on days 1 and 2.
- Arm II (standard + carboplatin schedule): Patients receive 5-FU and CF as in arm I plus carboplatin IV on day 1.
- Arm III (chronomodulated schedule): Patients receive 5-FU IV continuously and CF IV continuously on days 1-4.
- Arm IV (chronomodulated + carboplatin schedule): Patients receive 5-FU and CF as in arm III plus carboplatin IV continuously on days 1-4.
Quality of life is assessed. Treatment in all arms repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
Trial Contact Information
Trial Lead Organizations Groupe Regional d'Etudes du Cancer Colorectal - Belgium | | | | Christian Focan, MD, PhD, Protocol chair | | | |
Trial Sites
| Registry Information | | | Official Title | | 5-Fluorouracil-Leucovorin With or Without Carboplatin as Adjuvant Treatment for Primary Dukes B2-C Colon Cancer; Chronomodulated Versus Standard Administration. A Multicenter Randomized Phase III Trial of the GRECCR-Belgium (Study 03). | | | Trial Start Date | | 2001-05-01 | | | Registered in ClinicalTrials.gov | | NCT00046995 | | | Date Submitted to PDQ | | 2002-07-18 | | | Information Last Verified | | 2002-11-21 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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