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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 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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).


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:

No

Principal Investigator

Christian N.J. Focan, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Clinique Saint-Joseph

Authority:

United States: Federal Government

Study ID:

CDR0000257228

NCT ID:

NCT00046995

Start Date:

May 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the colon
  • stage IIB colon cancer
  • stage IIIA colon cancer
  • stage IIIB colon cancer
  • stage IIIC colon cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

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