Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux
Phase 3
18 Years
70 Years
18 Years
70 Years
Open (Enrolling)
Both
HNSCC
Both
HNSCC
Trial Information
Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux
Inclusion Criteria:
- Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx
- Stage III - IV (T0-T4, N0-N2b, M0)
- Not resected
- Karnofsky PS>=80
- Informed consent signed
Exclusion Criteria:
- Contra indication to chemotherapy or cetuximab
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Jean BOURHIS, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
GORTEC
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
GORTEC 2007-01
NCT ID:
NCT00609284
Start Date:
February 2008
Completion Date:
Related Keywords:
- HNSCC
- Stage III
- Stage IV
- locally advanced
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