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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	no age specified	NCI	EST-7283R

Objectives

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.

Outline

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

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