Phase II Study of Conservative Treatment of Adenocarcinoma of the Distal Rectum: Local Resection Followed by Adjuvant Radiotherapy with 5-FU Radiosensitization
Basic Trial Information
|Phase II||Treatment||Closed||18 and over||NCI||CLB-8984|
E-C8984, RTOG-9109, SWOG-9306, CALGB-8984
I. Determine whether survival among patients with T1-2 adenocarcinoma of the distal rectum treated conservatively with sphincter-sparing local resection followed by adjuvant radiotherapy plus fluorouracil is comparable to that of historical controls treated with radical, abdominoperineal resection. II. Determine whether survival among patients with T3 adenocarcinoma of the distal rectum treated conservatively is comparable to that of historical controls treated radically. III. Assess, as a function of stage, the locoregional recurrence rate of these patients treated with conservative surgery. IV. Determine the failure-free survival of these patients as a function of stage. V. Assess the toxicity of combining limited, sphincter-sparing surgery with postexcisional chemoradiotherapy in the treatment of less favorable low-lying adenocarcinoma of the rectum. VI. Determine the effects of sphincter-sparing surgery on bowel and bladder function and on sexual capacity. VII. Correlate clinical selection criteria (tumor size, circumferential involvement) with the ability to perform sphincter-sparing surgery. VIII. Refine quantitatively the following prognostically important factors for predicting survival and/or recurrence: tumor size, extent of circumferential involvement, depth of invasion, exophytic vs. endophytic growth, tumor grade, endothelial-lined vs. vascular space invasion, mucin production, patient age, gender, and pre- and postoperative CEA levels. IX. Determine the survival and failure free survival in these patients following abdominoperineal resection after a relapse from the original conservative sphincter sparing surgical procedure.
Biopsy-proven adenocarcinoma of the distal rectum Biopsy not required for patients with villous adenomas Proximal extent of tumor resection should not extend higher than 10 cm above the dentate line and must be below the pelvic peritoneal reflection Clinical Stage T1-3 disease required, as follows: No greater than 4 cm in diameter No more than 40% of the rectal circumference involved Clinical Stage T3 allowed only at ECOG and RTOG institutions No clinical or imaging evidence of regional lymph node involvement: Biopsy of palpable perirectal nodes or nodes larger than 1 cm on CT scan required prior to or at the time of surgery If no preoperative CT scan was performed, a postoperative scan with biopsy of enlarged nodes is required prior to postoperative registration Subtotal removal of tumors, removal of tumor in pieces, or microscopically positive margins following resection at an outside institution allowed provided complete transmural re-excision is performed at a member or affiliate institution The following disease states specifically excluded: Fixation to perirectal tissue Multifocal involvement Clinical evaluation by all treating physicians required prior to postoperative registration for T2 and T3 tumors (not required for T1 tumors)
Biologic therapy: No prior therapy Chemotherapy: No prior therapy Endocrine therapy: No prior therapy Radiotherapy: No prior therapy Surgery: See Disease Characteristics No prior definitive surgery Incomplete prior resection allowed Diagnostic biopsy allowed
Age: 18 and over Performance status: CALGB 0-2 Life expectancy: At least 2 years Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 130,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin less than 1.5 times normal SGOT/SGPT less than 1.5 times normal Renal: Creatinine less than 1.8 mg/dL BUN less than 1.5 times normal Other: No serious medical or psychiatric condition that would prevent informed consent No second malignancy within the past 5 years except: Inactive nonmelanomatous skin cancer In situ cervical cancer Not pregnant or nursing
300 patients will be accrued to obtain 195 eligible patients (90 patients with T1-2 rectal cancer and 105 patients with T3 rectal cancer) and results compared to 300 historical controls for each group who underwent abdominoperineal resection.
All patients undergo local excision of tumor. T1 patients are followed without further treatment. T2 and (T3 for ECOG or RTOG institutions) patients receive adjuvant radiotherapy plus fluorouracil. Patients are followed for survival.
Steele GD Jr, Herndon JE, Bleday R, et al.: Sphincter-sparing treatment for distal rectal adenocarcinoma. Ann Surg Oncol 6 (5): 433-41, 1999 Jul-Aug.[PUBMED Abstract]
Steele GD, Herndon JE, Burgess AM, et al.: Sphincter sparing treatment for distal rectal adenocarcinoma: a phase II intergroup study. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A908, 256a, 1997.
Greenberg JA, Shibata D, Herndon JE 2nd, et al.: Local excision of distal rectal cancer: an update of cancer and leukemia group B 8984. Dis Colon Rectum 51 (8): 1185-91; discussion 1191-4, 2008.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Radiation Therapy Oncology Group
Ph: 916-454-6699 ext. 80382
Southwest Oncology Group
Ph: 216-444-6480; 800-862-7798
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.