Capecitabine and Oxaliplatin or Standard Follow-Up Care in Treating Patients Who Have Undergone Surgery for Locally Advanced Rectal Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the rectum
• * Within 15 cm of the anal verge
• * Locally advanced disease
• Underwent complete resection of primary tumor within the past 12 weeks
• * ypT0-4, N0-2 with definitive histology at surgery
• * Circumferential resection margin \> 1 mm
• * No gross evidence of residual disease
• Received neoadjuvant fluoropyrimidine-based chemoradiotherapy with ≥ 45 Gy planned total radiation dose, given in 1 of the following fashions:
• * Prolonged fluorouracil IV during radiotherapy
• * Low-dose leucovorin calcium and fluorouracil (days 1-5 and 29-33) concurrently with radiotherapy
• * Oral capecitabine concurrently with radiotherapy
• No evidence of metastatic disease
• PATIENT CHARACTERISTICS:
• WHO performance status 0-1
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine clearance ≥ 50 mL/min
• Bilirubin ≤ 1.25 times upper limit of normal (ULN)
• AST and ALT ≤ 1.25 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• No known dihydropyrimidine dehydrogenase deficiency
• No hypersensitivity to platinum compounds
• No preexisting peripheral neuropathy ≥ grade 1
• No lack of physical integrity of the upper gastrointestinal tract
• No malabsorption syndrome
• No other serious uncontrolled medical condition or concurrent medical illness that would compromise life expectancy and/or preclude study compliance, including any of the following:
• * Serious uncontrolled infections
• * Significant cardiac disease (e.g., uncontrolled angina, congestive heart failure, cardiomyopathy, or arrhythmias) or myocardial infarction within the past 12 months
• * Interstitial pneumonia or symptomatic lung fibrosis
• No other malignancies except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin, unless disease-free for ≥ 10 years
• No history of uncontrolled seizures, CNS disorders, or psychiatric disability that would preclude study compliance
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No prior chemotherapy exceeding 6 weeks in duration
• * Prior chemotherapy given as part of neoadjuvant treatment (i.e., chemoradiotherapy) may last a maximum of 11-12 weeks
• No prior oxaliplatin
• Prior mitomycin C, irinotecan hydrochloride, or cetuximab allowed
• No concurrent warfarin, antiviral agents, or phenytoin