Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Treatment | Closed | no age specified | GITSG-7175 ITA-MIL-7505, MAYO-754701 |
Objectives
I. Compare the effects of postoperative radiotherapy with and without adjuvant chemotherapy alone on duration of disease-free interval, local recurrence rates and overall survial in patients who have undergone curative surgery for rectal carcinoma. II. Evaluate the prognostic value of immunocompetence tests and serum CEA assays as related to therapeutic response.
Entry Criteria
Disease Characteristics:
See General Eligibility Criteria
Patient Characteristics:
See General Eligibility Criteria
General Eligibility Criteria:
Histologically confirmed adenocarcinoma of the rectum, stages Dukes B2, C1 or C2, after curative resection of the primary tumor, without evidence of distant metastases. The distal edge of the primary must be less than or equal to 12 cm from the anal verge. No prior chemotherapy or radiotherapy.
Expected Enrollment
Protocol closed 09/80.
Outline
Randomized study. Enter patients within 60 days of curative surgery as follows: Arm I: Controls, withhold further therapy. Follow up observations only. (Arm closed February 25, 1980. Addendum 3, February 1980.) Arm II: Radiotherapy. Arm III: 2-Drug Combination Chemotherapy. 5-Fluorouracil, 5-FU, NSC-19893; Methyl CCNU, MeCCNU, NSC-95441. Arm IV: Radiotherapy plus 2-Drug Combination Chemotherapy. 5-FU, MeCCNU.Published Results
Thomas PR, Lindblad AS, Stablein DM, et al.: Toxicity associated with adjuvant postoperative therapy for adenocarcinoma of the rectum. Cancer 57 (6): 1130-4, 1986.[PUBMED Abstract]
Thomas PR, Stablein DM, Kinzie JJ, et al.: Perineal effects of postoperative treatment for adenocarcinoma of the rectum. Int J Radiat Oncol Biol Phys 12 (2): 167-71, 1986.[PUBMED Abstract]
Prolongation of the disease-free interval in surgically treated rectal carcinoma. Gastrointestinal Tumor Study Group. N Engl J Med 312 (23): 1465-72, 1985.[PUBMED Abstract]
Related PublicationsThomas PR, Lindblad AS: Adjuvant postoperative radiotherapy and chemotherapy in rectal carcinoma: a review of the Gastrointestinal Tumor Study Group experience. Radiother Oncol 13 (4): 245-52, 1988.[PUBMED Abstract]
Mayer RJ: Adjuvant therapy in rectal cancer: a protocol proposal. Semin Oncol 12 (3 Suppl 4): 116-20, 1985.[PUBMED Abstract]
Boice JD Jr, Greene MH, Killen JY Jr, et al.: Leukemia and preleukemia after adjuvant treatment of gastrointestinal cancer with semustine (methyl-CCNU). N Engl J Med 309 (18): 1079-84, 1983.[PUBMED Abstract]
Trial Lead Organizations
Gastrointestinal Tumor Study Group
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| Harold Douglass, MD, FACS, Protocol chair (Contact information may not be current) | |
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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.
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