Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the rectum, stage I rectal cancer
Eligibility Criteria
Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod status of =< 2 Patient must have histologically confirmed invasive adenocarcinoma of the rectum; Note: patients with rectal tumors suspicious for invasion also are eligible Distal border of the patient's tumor must be within 8 cm from the anal verge as measured on endoscopic exam Patients with tumors fixed to adjacent structures on digital exam are NOT eligible Patient must have an uT2uN0 tumor, as confirmed by endorectal ultrasound (ERUS) or endorectal coil magnetic resonance imaging (MRI) scan; patients with uT1, uT3, or uT4 tumors are NOT eligible; greatest diameter of tumor cannot exceed 4 cm Patients with positive perirectal nodes on ERUS examination are NOT eligible Patients with histologic evidence of metastatic invasion of inguinal lymph nodes are NOT eligible Patients with the following conditions are NOT allowed on study: Metastatic disease or other primaries (patient must have had chest X-ray/computed tomography [CT] and abdominal & pelvic CT/MRI with IV contrast, as well as a colonoscopy) Previously documented history of familial adenomatous polyposis Previously documented history of hereditary non-polyposis colorectal cancer diagnosed clinically (Amsterdam II criteria) or by genetic testing History of inflammatory bowel disease History of prior radiation treatments to pelvis Clinically significant peripheral sensory or motor neuropathy (defined as symptomatic weakness, paresthesia or sensory alteration described to be interfering with function, interfering with activities of daily living, disabling or life-threatening) History of any clinically significant cardiac disease (i.e., class 3-4 congestive heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia, and/or myocardial infarction within the last 6 months) History of uncontrolled seizures or clinically significant central nervous system disorders History of psychiatric conditions or diminished mental capacity that could compromise the giving of informed consent, or interfere with study compliance History of allergy and/or hypersensitivity to capecitabine and/or oxaliplatin History of difficulty or inability to take or absorb oral medications White blood cells (WBC) >= 3000/mm^3 Absolute neutrophil count (ANC) > 1,500/mm^3 Hemoglobin > 9.5 mg/dl Platelet count >= 100,000/mm^3 Total bilirubin =< 3 mg/dl Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0 times institutional upper limit of normal (ULN) Alkaline phosphatase =< 2.0 times ULN Creatinine clearance (CLcr) >= 50 ml/min by Cockroft-Gault equation Patients who have experienced a prior malignancy must have received potentially curative therapy for that malignancy, and must be cancer-free for at least five years from the date of initial diagnosis (exceptions: patients treated for non-melanoma skin carcinoma, or in-situ carcinomas) Patients of reproductive potential must agree to use an effective method of birth control when undergoing treatments with known or possible mutagenic or teratogenic effects; all female participants of childbearing potential must have a negative urine or serum pregnancy test within two weeks prior to study registration
Sites / Locations
- Mayo Clinic Scottsdale
- Cancer Care Center at John Muir Health - Concord Campus
- City of Hope Comprehensive Cancer Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- John Muir/Mt. Diablo Comprehensive Cancer Center
- St. Vincent's Medical Center
- Praxair Cancer Center at Danbury Hospital
- Mayo Clinic - Jacksonville
- Tampa General Hospital
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- University of Chicago Cancer Research Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Indiana University Melvin and Bren Simon Cancer Center
- William N. Wishard Memorial Hospital
- Reid Hospital & Health Care Services
- Ochsner Cancer Institute at Ochsner Clinic Foundation
- Mayo Clinic Cancer Center
- Altru Cancer Center at Altru Hospital
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Charles F. Kettering Memorial Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- Clinton Memorial Hospital
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Integris Oncology Services
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Providence Cancer Center at Providence Portland Medical Center
- Knight Cancer Institute at Oregon Health and Science University
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- UPMC Cancer Center at Beaver Medical Center
- UPMC Cancer Center at Jefferson Regional Medical Center
- UPMC Cancer Center - Arnold Palmer Pavilion
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- UPMC Cancer Center at the John P. Murtha Pavilion
- UPMC - Moon
- UPMC Cancer Center - Natrona Heights
- Jameson Memorial Hospital - North Campus
- Fox Chase Cancer Center - Philadelphia
- Allegheny Cancer Center at Allegheny General Hospital
- UPMC - Shadyside
- UPMC Cancer Center at Magee-Womens Hospital
- UPMC Cancer Center at UPMC Presbyterian
- UPMC Cancer Center at UPMC St. Margaret
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- UPMC Cancer Centers
- UPMC Cancer Center at UPMC Passavant
- St. Clair Memorial Hospital Cancer Center
- UPMC Cancer Center at UPMC Northwest
- Washington Hospital Cancer Center
- Vanderbilt-Ingram Cancer Center
- M. D. Anderson Cancer Center at University of Texas
- Methodist Hospital
- Surgical Oncology Associates
- Providence Cancer Center at Sacred Heart Medical Center
- Providence Cancer Center at Holy Family Hospital
- United Hospital Center
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (capecitabine, oxaliplatin, radiotherapy, surgery)
Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.