Phase III Randomized Study of Total Mesorectal Excision With vs Without Preoperative Radiotherapy in Patients With Primary Rectal Cancer (Summary Last Modified 03/2000)
Radiation Therapy Before or After Surgery in Treating Patients With Primary Rectal Cancer
Basic Trial Information
|Phase III||Treatment||Closed||18 and over||DUT-KWF-CKVO-9504|
I. Compare the local control rate following standardized total mesorectal excision (TME) with or without preoperative radiotherapy in patients with primary rectal cancer. II. Compare the quality of life of patients in each treatment group. III. Achieve standardization and quality control of TME surgery and pathologic assessment in rectal cancer. IV. Assess the cost-benefit ratio associated with each treatment.
Histologically proven stage T2-3 primary adenocarcinoma of the rectum Tumor located below S1/S2 Distal border of tumor within 15 cm of the anal verge Tumor judged to be clinically resectable with negative margins (R0) No tumors fixed to the pelvic wall, prostate, or bladder No tumors that can be locally excised in the surgeon's opinion No clinically documented synchronous, distant metastases No hereditary non polyposis colorectal cancer or familial adenomatosis polyposis
Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the pelvis Surgery: No prior partial resection or left-sided large bowel and/or rectum No prior multiple and/or pelvic surgical procedures No emergency surgery
Age: 18 and over Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy except adequately treated: Basal cell skin cancer Carcinoma in situ of the cervix Able to complete follow-up
A total of 1,400 patients will be accrued for this study over 3 years.
This is a randomized, multicenter study. Patients are stratified according to center and expected resection type (low anterior resection vs abdominoperineal resection). Patients are randomized to one of two treatment arms. Arm I: Patients undergo abdominoperineal or low anterior resection. Some patients also receive radiotherapy 5 days a week for 5.5 weeks following surgery. Arm II: Patient receive radiotherapy for 5 days followed by surgery. Patients are followed every 3 months for 1 year, then annually for 2 years.
Kapiteijn E, Kranenbarg EK, Steup WH, et al.: Total mesorectal excision (TME) with or without preoperative radiotherapy in the treatment of primary rectal cancer. Prospective randomised trial with standard operative and histopathological techniques. Dutch ColoRectal Cancer Group. Eur J Surg 165 (5): 410-20, 1999.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Leiden University Medical Center
European Organization for Research and Treatment of Cancer
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.