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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosedno age specifiedNCIEST-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.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

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.

Expected Enrollment

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.

Published Results

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

Benjamin Sischy, MD, FACR, Protocol chair (Contact information may not be current)
Ph: 716-341-6750

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.