Combination Chemotherapy for 3 Months or 6 Months in Treating Patients With Stage III Colon Cancer

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective when given for 3 months or 6 months in treating patients with colon cancer.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy for 3 months to see how well it works compared with giving combination chemotherapy for 6 months in treating patients with stage III colon cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Calcium; Capecitabine; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed colon cancer

• Tumor location > 12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery (high rectum)

• AJCC/UICC stage III disease

• Adenocarcinoma

• No evidence of metastatic disease (including presence of tumor cells in ascites or peritoneal carcinomatosis resected "en bloc")

• Undergone curative surgery for colon cancer within the past 8 weeks

• No gross, macroscopic, or microscopic evidence of residual disease (R1 or R2 resections) after surgery

• Carcinoembryonic antigen ≤ 10 ng/mL (2 times normal)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and up to 1 month after completion of study treatment

• Willing and able to comply with study requirements

• No clinically relevant cardiovascular disease (ischemic myocardial infarction in the past year and/or unstable ischemic cardiopathy)

• No other malignancies within the past 5 years except for curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix

• No history or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ CTCAE v.3.0 grade 1

• No known hypersensitivity reaction to any of the components of study treatments

• Registered in a national health care system (CMU included)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 28 days since prior treatment, no concurrent treatment, and no treatment while the patient is disease-free during study follow-up with another investigational drug

• No concurrent treatment or treatment while the patient is disease-free during study follow-up with other cytotoxic agents, or active or passive immunotherapy for colon cancer