Trial Information

Continuous Fluorouracil Plus Mitomycin C Versus Mitomycin C Plus Cisplatin As Chemotherapy Combination In Combined Radiochemotherapy For Locally Advanced Anal Cancer. A Phase II-III Study

OBJECTIVES:

Phase II

- Primary

- Compare the early clinical response (tumor response at 8 weeks) of patients with
locally advanced anal cancer treated with radiotherapy with mitomycin and
cisplatin vs mitomycin and fluorouracil.

- Secondary

- Compare the feasibility of these regimens in these patients.

- Compare the acute toxicity of these regimens in these patients.

- Compare patient compliance to these regimens.

Phase III

- Primary

- Compare the event-free survival of patients treated with these regimens.

- Secondary

- Compare colostomy-free, disease-free, and overall survival of patients treated
with these regimens.

- Compare locoregional control in patients treated with these regimens.

- Compare the late toxicity of these regimens in these patients.

- Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, T stage (T2 vs T3 vs T4), and nodal status (N0 vs N+). Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo radiotherapy once daily 5 days a week on weeks 1-4, 7-8, and 3
days of week 9 (total of 33 fractions). Patients concurrently receive fluorouracil IV
continuously on days 1-26 and 43-59 and mitomycin IV over 15 minutes on days 1 and 43.

- Arm II: Patients receive radiotherapy and mitomycin as in arm I and cisplatin IV over 1
hour on days 1, 8, 15, 22, 43, 50, and 57.

In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.

Quality of life is assessed at baseline, at weeks 12 and 26, and then every 6 months for 2
years.

Patients are followed every 2 weeks for 8 weeks, at week 26, and then every 6 months
thereafter.

PROJECTED ACCRUAL: A total of 678 patients (80 [40 per treatment arm] for phase II and 598
[299 per treatment arm] for phase III) will be accrued for this study within 2-5 years.