Phase II Evaluation of Radiotherapy with 5-FU/MITO as Radiosensitization Followed by Biopsy with or without Abdominoperineal Resection for Squamous Cell and Basaloid Carcinoma of the Anal Canal
Basic Trial Information
|Phase II||Treatment||Closed||no age specified||NCI||EST-7283R|
I. Determine the effectiveness of the combination of radiotherapy and chemotherapy with 5-fluorouracil/mitomycin-C used as a radiation potentiator in the treatment of squamous cell carcinoma of the anus. II. Determine the extent to which the combination of radiotherapy and chemotherapy used as a radiation potentiator is locally curative and obviates the necessity of an abdominoperineal resection.
See General Eligibility Criteria
See General Eligibility Criteria
General Eligibility Criteria:
Patients with histologically proven measurable squamous cell carcinoma of the anal canal other than carcinoma in situ. Patients may have any T stage disease and must be suitable for full thickness biopsy and potential abdominoperineal resection. There may be no evidence of nodal involvement or distant metastases. Patients with prior radiotherapy, chemotherapy, or surgery for cancer of the anus, except for biopsy, are ineligible. An ECOG performance status of 0-2 and adequate hepatic, renal, and bone marrow function are required. Patients with other primary malignancies (excluding skin cancers) are ineligible. Upon reactivation of the protocol in September 1984, entry criteria were revised as follows: patients must have T1, T2, T3, or T4 (if posterior vaginal wall is involved) disease; patients with disease extension to the prostate or bladder are not eligible.
An accession rate of about 12 evaluable patients per year is anticipated; about 3.3 years will be required to meet an accrual objective of 40 evaluable patients. In May 1984, the protocol was temporarily suspended, pending reissue of a revised protocol. Protocol was reactivated in revised form in September 1984.
Nonrandomized study. 2-Drug Radiosensitization plus Radiotherapy plus Surgery. 5-Fluorouracil, 5-FU, NSC-19893; Mitomycin-C, MITO, NSC-26980; plus pelvic and perineal irradiation with teletherapy or supervoltage equipment; plus full thickness biopsy of tissue, with abdominoperineal resection as required.
Sischy B, Lefkopoulou M, Mittleman A, et al.: Interim report of EST 7283: a phase II study to evaluate the effectiveness of 5FU and mitomycin C combined with irradiation in the management of carcinoma of the anal canal. [Abstract] Proceedings of the American Society of Clinical Oncology 7: A-412, 107, 1988.
Trial Contact Information
Trial Lead Organizations
Eastern Cooperative Oncology Group
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.