Clinical trial NCT00427713 (phase 3, status: completed)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: capecitabine, oxaliplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        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