Trial | NCT00046995  Report issue

Title

Combination Chemotherapy in Treating Patients With Colon Cancer
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).

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    800
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.
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.
Study Started
May 31
2001
Last Update
Sep 20
2013
Estimate

Drug carboplatin

Drug fluorouracil

Drug leucovorin calcium

Procedure adjuvant therapy

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
No Results Posted