Current Clinical Trials at UIHC: GI Oncology Protocols: High Risk Anal Cancer
James R. Howe, M.D.
Peer Review Status: Internally Peer
Reviewed
Objective:
In the RTOG study, locoregional control was 82% for tumors < 3 cm, while only 62% for those > 3 cm, and survival 85% vs. 68%. These differences were not significant because some of the latter patients were salvaged by surgery. The prognosis of those with nodal involvement remains substantially worse than those without 42% versus 19% died), and therefore new treatment modalities are warranted in these high-risk patients.
Cisplatin and 5-FU have been shown to be an effective combination in other epidermoid cancers (cervix, esophagus, head and neck).
Patients with T3 (> 5 cm) or T4 (invading adjacent organs) tumors or N2 (internal iliac or inguinal nodes) or N3 (perirectal and inguinal or int. iliac, or bilateral inguinal, int. iliac) disease are eligible.
2 cycles of induction therapy with Cisplatin/5-FU will be given, followed by 4500 cGY of radiation plus 2 cycles of Mitomycin-C5-FU. Patients will then be re-staged, and if no residual disease, no further treatment is given. If disease remains, additional XRT (900 cGY) to affected area and Cisplatin/5-FU are given.
If disease remains, then abdominoperineal resection is performed.
The projected accrual is 45 pts., and 22 had been entered over 3 years (2 from Iowa).
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