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Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence


OBJECTIVES:

- Compare the effect of leucovorin calcium and fluorouracil with or without irinotecan on
the 3 year survival rate and overall survival of patients with resected node positive
colon cancer at high risk of recurrence.

- Compare toxicities of these regimens in these patients.

- Compare quality of life of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, disease type (occlusion vs perforation vs N2 only), delay between surgery and
chemotherapy (28 days or less vs over 28 days), and age (under 65 vs 65 and over). Patients
are randomized to one of two treatment arms.

- Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22
hours on days 1 and 2.

- Arm II: Patients receive irinotecan IV over 90 minutes on day 1 followed by leucovorin
calcium and fluorouracil as in arm I.

Treatment repeats every 14 days for up to 12 courses in the absence of disease progression
or unacceptable toxicity.

Quality of life is assessed before treatment, after 6 and 12 courses, and then at 1 year.

Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study
within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven stage III adenocarcinoma of the colon that has been curatively
resected within past 42 days

- No metastatic disease

- Node positive

- No more than 4 nodes affected (Tx, N2, M0) AND/OR

- N1 or N2 with perforation and/or occlusion

- No prior rectal cancer within 10 cm of anal margin or that was treated with
preoperative radiotherapy

- No prior inflammatory disease of the intestine

PATIENT CHARACTERISTICS:

Age:

- 18 to 75

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Neutrophil count at least 2,000/mm3

- Platelet count at least 100,000/mm3

Hepatic:

- Bilirubin less than 1.25 times upper limit of normal (ULN)

- SGOT and SGPT less than 3 times ULN

- Alkaline phosphatase less than 3 times ULN

Renal:

- Not specified

Cardiovascular:

- No myocardial infarction within past 6 months

- No insufficient cardiac function

Other:

- No other serious medical illness

- No active infection

- No other malignancy except skin cancer or carcinoma in situ of the cervix

- No psychological or social condition that would preclude study

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

Surgery:

- See Disease Characteristics

- No prior extensive intestinal resection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Marc Ychou, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Val d'Aurelle - Paul Lamarque

Authority:

United States: Federal Government

Study ID:

CDR0000067967

NCT ID:

NCT00005979

Start Date:

February 1998

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage III colon cancer
  • adenocarcinoma of the colon
  • Colonic Neoplasms
  • Colorectal Neoplasms

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