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Clinical Trials (PDQ®)

Adjuvant Radiotherapy and Chemotherapy with 5-FU/MeCCNU Following Curative Resection for Rectal Adenocarcinoma

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedTreatmentClosedno age specifiedGITSG-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 Publications

Thomas 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 Contact Information

Trial Lead Organizations

Gastrointestinal Tumor Study Group

Harold Douglass, MD, FACS, Protocol chair (Contact information may not be current)
Ph: 716-845-5738; 800-685-6825
Email: harold.douglass@roswellpark.org

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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