A Phase III Randomized Multicenter Study,Comparing an Induction Chemotherapy Followed by Irradiation and Concurrent Erbitux Versus Chemoradiotherapy for Patients With Locoregional Advanced Head and Neck Cancers
18 Years
70 Years
Both
Squamous Cell Head and Neck Carcinoma
Trial Information
A Phase III Randomized Multicenter Study,Comparing an Induction Chemotherapy Followed by Irradiation and Concurrent Erbitux Versus Chemoradiotherapy for Patients With Locoregional Advanced Head and Neck Cancers
Concurrent chemoradiotherapy (radiotherapy+ carboplatin + 5FU) is a validated treatment for
patients with locoregional advanced head and neck cancers.
This study evaluates the outcome of induction chemotherapy (docetaxel, cisplatin, 5 FU)
followed by radiation therapy + Erbitux for patients with head and neck carcinoma with
almost one measurable lesion by RMI or CT scan.
We hope we can improve the progression free survival of 14% at two years .
Inclusion Criteria:
- head and neck locally advanced,non metastatic carcinoma
- not suitable for surgery
Exclusion Criteria:
- non squamous cell head and neck cancer
- previous malignancy
- previous treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete response rate of the treatment
Outcome Description:
measure of the tumor
Outcome Time Frame:
by CT scan or MRI and endoscopy 2 years after the end of treatment
Safety Issue:
No
Principal Investigator
Lionnel GEOFFROIS, oncologist
Investigator Role:
Study Director
Investigator Affiliation:
Centre Alexis Vautrin NANCY France
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
GORTEC 2007-02
NCT ID:
NCT01233843
Start Date:
May 2009
Completion Date:
May 2015
Related Keywords:
- Squamous Cell Head and Neck Carcinoma
- induction chemotherapy
- followed by irradiation and concurrent Erbitux, or radiochemotherapy
- Carcinoma
- Head and Neck Neoplasms
- Carcinoma, Squamous Cell
Name | Location |
|---|
