Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the rectum
Eligibility Criteria
Inclusion Criteria: Patients must have an Eastern Cooperative Oncology Group (ECOG) Status of 0 or 1, or comparable Karnofsky performance status Patients must have histologically confirmed invasive adenocarcinoma of the rectum Distal border of the tumor must be within 12 cm from the anal verge as measured on rigid proctoscopic exam Patients must have Stage II (uT3-4, uN0) or Stage III (any T, uN1-2) tumors, as confirmed by ERUS or MRI; females with anterior tumors invading the posterior vaginal wall (uT4) and males with anterior tumors that invade the seminal vesicles or adjacent organs (uT4) will also be eligible provided they undergo an extended resection including the organs involved Patients with high grade obstruction that impedes the ERUS exam are eligible for the study provided they can be staged by MRI Patients with synchronous or metachronous colorectal cancer are eligible for the study on condition that they are treated for rectal cancer in accordance with the protocol Patients with the following are NOT allowed on study: Metastatic disease or other primaries Locally recurrent rectal cancer Previously documented history of Familial Adenomatous Polyposis History of Inflammatory Bowel Disease History of prior radiation treatments to pelvis History of clinically significant cardiac disease (i.e., Class 3-4 congestive heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia, and/or myocardial infarction within the previous 6 months History of uncontrolled seizures or clinically significant central nervous system disorders History of psychiatric conditions or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance History of allergy and/or hypersensitivity to 5-fluorouracil (fluorouracil), leucovorin (leucovorin calcium), and/or oxaliplatin History of difficulty or inability to take or absorb oral medications Patients must have adequate bone marrow, hepatic and renal function within 7 days prior to registration White blood cells (WBC) >= 3,000 mm^3 Absolute neutrophil count (ANC) > 1,500 mm^3 Hemoglobin > 9.5 mg/dl Platelet count >= 100,000 mm^3 Total bilirubin =< 1.5 mg/dl Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.0 times institutional upper limit of normal (ULN) Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.0 times ULN Alkaline phosphatase =< 2.0 times ULN Serum creatinine =< 1.5 times ULN Patients with hereditary non-polyposis colorectal cancer are eligible for the study provided they meet the rest of the eligibility criteria Patients who have experienced a prior malignancy should have received potentially curative therapy for that malignancy, and should be cancer-free for at least five years from the date of initial diagnosis (Exceptions: patients treated for basal cell carcinoma, or carcinoma in-situ of the cervix) Patients of reproductive potential should 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 Patients or the patient's legally acceptable representative must provide written authorization to allow the use and disclosure of protected health information; NOTE: this may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration or the initiation of any study-specific procedures
Sites / Locations
- Cancer Care Center at John Muir Health - Concord Campus
- City of Hope Medical Center
- St. Joseph Hospital Regional Cancer Center - Orange
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- UCSF Helen Diller Family Comprehensive Cancer Center
- Washington Cancer Institute at Washington Hospital Center
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- University of Chicago Cancer Research Center
- Masonic Cancer Center at University of Minnesota
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Colon and Rectal Surgery, Incorporated
- Cleveland Clinic Taussig Cancer Center
- Knight Cancer Institute at Oregon Health and Science University
- Vermont Cancer Center at University of Vermont
- Tom Baker Cancer Centre - Calgary
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Group 1 (Closed to Enrollment)
Group 2 (Closed to Enrollment)
Group 3 (chemotherapy, FOLFOX, conventional surgery)
Group 4 (chemotherapy, FOLFOX, conventional surgery)
All patients undergo chemoradiation therapy comprising radiation therapy once daily 5 days a week for 5 weeks and fluorouracil intravenously continuously over 24 hours 7 days a week for 6 weeks. Patients undergo standard surgical resection after completion of chemoradiation therapy..
All patients undergo chemoradiation therapy comprising radiation therapy once daily 5 days a week for 5 weeks and fluorouracil IV continuously over 24 hours 7 days a week for 6 weeks. Beginning 4 weeks after completion of chemoradiation therapy, patients receive modified FOLFOX-6 chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1-2. Treatment repeats every 14 days for 2 courses. After the last week of post-radiation chemotherapy, patients undergo standard surgical resection.
All patients undergo chemoradiation therapy comprising radiation therapy once daily 5 days a week for 5 weeks and fluorouracil IV continuously over 24 hours 7 days a week for 6 weeks. Beginning 4 weeks after completion of chemoradiation therapy, patients receive modified FOLFOX-6 chemotherapy as in group II. Treatment repeats every 14 days for 4 courses. After the last week of post-radiation chemotherapy, patients undergo standard surgical resection.
All patients undergo chemoradiation therapy comprising radiation therapy once daily 5 days a week for 5 weeks and fluorouracil IV continuously over 24 hours 7 days a week for 6 weeks. Beginning 4 weeks after completion of chemoradiation therapy, patients receive modified FOLFOX-6 chemotherapy as in group II. Treatment repeats every 14 days for 6 courses. After the last week of post- radiation chemotherapy, patients undergo standard surgical resection. Patients then receive 3 additional courses of FOLFOX-6 chemotherapy or other chemotherapy off study as directed by the physician.