Chemotherapy, Radiation Therapy, and Cetuximab in Treating Patients With the Head and Neck Cancer
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with radiation therapy and cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well chemotherapy given together with radiation therapy and cetuximab works in treating patients with head and neck cancer.
|Head and Neck Cancer||Biological: cetuximab Drug: cisplatin Radiation: radiation therapy||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Disease-free survival at 2 years [ Time Frame: 2 YEARS ]
|Study Start Date:||March 2008|
|Study Completion Date:||December 2013|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
|Experimental: Cetuximab||Biological: cetuximab Drug: cisplatin Radiation: radiation therapy|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875849
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Principal Investigator:||Philippe Follana||Centre Antoine Lacassagne|