Clinical Trials

Clinical TrialsClinical Trials

Anal cancer stage I was formerly treated with abdominoperineal resection. Current therapies in preserving the sphincter include wide local excision of the perianal skin or anal margin for small tumors, or definitive chemoradiation (fluorouracil, and mitomycin) for cancers of the anal canal. Salvage chemoradiation therapy (fluorouracil and cisplatin plus a radiation boost) may avoid permanent colostomy in patients with residual tumor after undergoing initial nonoperative therapy. Radical resection is reserved for patients with incomplete responses or recurrent disease. It is therefore important continuous surveillance with rectal examination every three months during the first two years and endoscopy / biopsy when indicated after completion of sphincter-preserving therapy.

Standard treatment options:

1. Small tumors of the perianal skin or anal margin not involving the anal sphincter may be adequately treated with local resection.

2. As evidenced in RTOG-9208 and RTOG-8314, all other types of cancer of the anal canal which stage I involving the anal sphincter or are too large for complete local excision receive external beam radiotherapy (EBRT) with or without chemotherapy.

Chemotherapy with fluorouracil and mitomycin combined with primary radiation therapy appears more effective than radiotherapy alone. The optimal dose of radiation with concurrent chemotherapy is under clinical evaluation (RTOG 9811).

Selected tumors are also suitable for interstitial radiation therapy.

3. The Radical resection is reserved for residual cancer or recurrent anal canal after nonoperative therapy.

4. Alternately, salvage chemotherapy with fluorouracil and cisplatin combined with a radiation boost may avoid permanent colostomy in selected patients with small amounts of residual tumor following initial nonoperative therapy.

5. Iridium-192 interstitial after EBRT may convert some patients with residual disease in patients who respond to treatment in a comprehensive manner.

Clinical Trials

Consult the Register of Clinical Trials NCI’s PDQ Cancer (NCI’s PDQ Cancer Clinical Trials Registry) to enter clinical trials performed in the United States and are accepting patients. To search, use the English word stage I anal cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

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