Combination Chemotherapy in Treating Patients With Colon Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2002 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Groupe Regional d'Etudes du Cancer Colorectal
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00046995
First received: October 3, 2002
Last updated: November 12, 2010
Last verified: November 2002
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which schedule of chemotherapy is most effective in treating colon cancer.
PURPOSE: Randomized phase III trial to compare different schedules of chemotherapy using carboplatin with fluorouracil and leucovorin in treating patients who have stage IIB or stage III colon cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: carboplatin Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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). |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Disease-free survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tolerability [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
| Estimated Enrollment: | 800 |
| Study Start Date: | May 2001 |
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.
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.
PROJECTED ACCRUAL: A total of 660-800 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon
- Stage IIB or III (Dukes stage B2 or C)
- 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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1 OR
- Karnofsky 60-100%
Life expectancy
- Not specified
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
- Fertile patients must use effective contraception
- No concurrent infectious disease
- No other malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior immunotherapy
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy (before or after surgery)
Surgery
- See Disease Characteristics
Other
- No concurrent participation in another clinical trial
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046995
Locations
| Belgium | |
| Centre Hospitalier Hutois | |
| Huy, Belgium, 4500 | |
| Clinique Saint-Joseph | |
| Liege, Belgium, B 4000 | |
Sponsors and Collaborators
Groupe Regional d'Etudes du Cancer Colorectal
Investigators
| Study Chair: | Christian N.J. Focan, MD, PhD | Clinique Saint-Joseph |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00046995 History of Changes |
| Other Study ID Numbers: | CDR0000257228, GRECCR-03, EU-20201 |
| Study First Received: | October 3, 2002 |
| Last Updated: | November 12, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the colon stage IIB colon cancer stage IIIA colon cancer stage IIIB colon cancer stage IIIC colon cancer |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Adjuvants, Immunologic Fluorouracil Carboplatin |
Leucovorin Levoleucovorin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013