Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients With Anal Cancer
- Compare the response rates in patients with primary epidermoid anal cancer treated with
radiotherapy and fluorouracil with either mitomycin or cisplatin and with or without
- Compare local control and prevention or delay of disease dissemination in patients
treated with these regimens.
OUTLINE: This is randomized, open-label, multicenter study. Patients are randomized to one
of four treatment arms.
All patients undergo radiotherapy daily 5 days a week for 5.5 weeks. All patients also
receive fluorouracil IV continuously over days 1-4 and 29-32.
- Arm I: Patients receive mitomycin IV on day 1.
- Arm II: Patients receive cisplatin IV on days 1 and 29.
- Arm III: Patients receive mitomycin as in arm I and maintenance therapy comprising
fluorouracil IV continuously over days 1-4 and cisplatin IV on day 1 beginning 4-8
weeks after completion of primary therapy and repeating once 3 weeks later.
- Arm IV: Patients receive cisplatin as in arm II and maintenance therapy as in arm III.
Patients are followed at 2 months, every 3 months for 2 years, every 6 months for 3 years,
and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 600 patients (150 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Complete response rate at 6 months
Roger D. James, MD