NCT00068744

Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as mitomycin, fluorouracil, and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy and mitomycin are more effective when combined with fluorouracil or with cisplatin in treating anal cancer . PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy and mitomycin together with fluorouracil works compared to radiation therapy, mitomycin, and cisplatin in treating patients with locally advanced anal cancer.

Detailed description

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.

Conditions

• Anal Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	fluorouracil
DRUG	mitomycin C
RADIATION	radiation therapy

Timeline

• Start date: 2003-07-01
• Primary completion: 2007-11-01
• First posted: 2003-09-11
• Last updated: 2012-09-24

Locations

24 sites across 7 countries: Belgium, Egypt, France, Germany, Italy, Netherlands, Serbia