Phase II Evaluation of Radiotherapy with 5-FU/MITO as Radiosensitization Followed by Biopsy with/without Abdominoperineal Resection for Anal Cancer (Summary Last Modified 06/1999)

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentCompleted75 and underNCIRTOG-8314


I.  Estimate the effectiveness in terms of an 8-week local control rate 
confirmed by biopsy of a combination of radiotherapy and chemotherapy used as 
a radiation potentiator in the treatment of squamous cell and baseloid 
carcinoma of the anus.
II.  Investigate whether this combination of radiotherapy and chemotherapy 
used as a radiation potentiator is locally curative in a large enough 
proportion of cases to recommend it as standard practice instead of initial 
abdominoperineal resection.
III.  Investigate the long-term efficacy of this treatment in terms of one and 
three year local control rates.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at most 75 years of age (age 
requirement deleted per February 1986 amendment) with histologically proven 
measurable squamous cell or baseloid 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 following treatment, with a potential for 
abdominoperineal resection.  There must be a Karnofsky performance status of 
60 or better and adequate hematologic, renal, and hepatic functions.  Patients 
with evidence of recurrent or persistent disease following prior surgery or 
radiotherapy to the anus are ineligible for study entry, as are those with 
evidence of nodal involvement, distant metastases, or other primary 
malignancies (excluding skin cancer).

Expected Enrollment

Estimated accrual rate is 20 patients per year for 1.5 years.


Nonrandomized study.
2-Drug Radiosensitization plus Radiotherapy plus Surgery.  5-Fluorouracil, 
5-FU, NSC-19893; Mitomycin-C, MITO, NSC-26980; plus pelvic and nodal 
irradiation with Co60 source or 4 MeV or greater equipment; plus full 
thickness biopsy of tissue, with abdominoperineal resection as required.

Published Results

Sischy B, Doggett RL, Krall JM, et al.: Definitive irradiation and chemotherapy for radiosensitization in management of anal carcinoma: interim report on Radiation Therapy Oncology Group study no. 8314. J Natl Cancer Inst 81 (11): 850-6, 1989.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Radiation Therapy 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.