Phase II Study Evaluating Radiotherapy-chemotherapy and Cetuximab in Patients With Histologically Proven Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx and With a Poor Prognosis After Complete Surgical Resection
- Evaluate disease-free survival at 2 years in patients with poor prognosis squamous cell
carcinoma of the head and neck treated with chemoradiotherapy and cetuximab after
complete surgical resection.
- Evaluate quality of life.
- Evaluate tolerability.
- Evaluate overall survival.
- Analyze germinal polymorphisms.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV on day 1. Treatment with cetuximab repeats every week for up
to 8 courses. Patients also receive cisplatin IV on day 8. Treatment with cisplatin repeats
every 3 weeks for up to 3 courses. Patients undergo concurrent radiotherapy 5 times a week
for 7 weeks beginning on day 8.
After completion of study treatment, patients are followed at 1 month and then every 3
months for 2 years.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival at 2 years
Centre Antoine Lacassagne