Phase II Nonrandomized Multicenter Study of the Impact of Radiochemotherapy (65 Gy + Cisplatin + 5FU) Combined With Cetuximab in Patients Presenting With Locally Advanced Anal Cancer
- Evaluate the objective response (complete and partial) 8 weeks after completion of
study treatment comprising radiotherapy, chemotherapy (fluorouracil and cisplatin), and
cetuximab followed by additional radiotherapy in patients with locally advanced anal
- Evaluate colostomy-free survival.
- Evaluate the local control rate (objective response and stabilization) at 8 weeks.
- Evaluate relapse-free survival at 5 years.
- Evaluate the intermediate objective response at the end of week 5 of radiotherapy.
- Evaluate overall survival at 5 years.
- Evaluate the duration of response.
- Evaluate acute toxicities according to CTCAE v3.0.
- Evaluate late toxicities at 5 years according to CTCAE v3.0.
- Study the tumor markers associated with response (survival without relapse) and
- Study the genotypes of Fc-receptor immunoglobulins (FCGR2A and FCGR3) and their
association with skin toxicity, objective survival, and relapse-free survival.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV on days 0, 7, 14, 21, 28, and 35; fluorouracil IV on days 7-10
and 35-38; and cisplatin IV over 2 hours on days 7 and 35. Beginning on day 7, patients also
undergo radiotherapy 5 days a week for 5 weeks (weeks 2-6). Two weeks after finishing this
treatment, patients undergo additional radiotherapy* 5 days a week for 2 weeks (weeks 9 and
NOTE: *Some patients may undergo brachytherapy.
Blood and tissue samples are collected for further analysis.
After completion of study treatment, patients are followed up for 4 years.
Allocation: Non-Randomized, Primary Purpose: Treatment
Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment
Eric Deutsch, MD
Gustave Roussy, Cancer Campus, Grand Paris
United States: Federal Government