Oxaliplatin, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Rectum
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the rectum, stage III rectal cancer, stage II rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the rectum Tumor involving the distal 12 cm of the rectum (above the anal verge) Clinically staged by endoscopic ultrasound with one of the following criteria: T3-T4 disease Evidence of lymph node involvement, defined by the presence of ≥ 1 enlarged peri-rectal lymph node (≥ 1 cm in size) No known distant metastases PATIENT CHARACTERISTICS: Age 18 to 75 Performance status ECOG 0-1 OR Karnofsky 70-100% Life expectancy More than 1 year Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal AST and ALT ≤ 2.5 times upper limit of normal Renal Creatinine normal OR Creatinine clearance ≥ 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Able to receive oral medication No other malignancy within the past 5 years except nonmelanoma skin cancer No prior or concurrent significant neuropathy No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs No ongoing or active infection No other concurrent uncontrolled illness No psychiatric illness or social situation that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-method contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent granulocyte-stimulating factors Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy No prior pelvic radiotherapy Surgery Not specified Other No other concurrent investigational agents No other concurrent anticancer agents or therapies
Sites / Locations
- Roswell Park Cancer Institute