NCT00609284
Completed
Phase 3
Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux
Groupe Oncologie Radiotherapie Tete et Cou5 sites in 1 country406 target enrollmentFebruary 15, 2008
ConditionsHNSCC
Overview
- Phase
- Phase 3
- Intervention
- cetuximab
- Conditions
- HNSCC
- Sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Enrollment
- 406
- Locations
- 5
- Primary Endpoint
- Progression free survival
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
Radiotherapy 70Gy, Erbitux, Carboplatin-5FU
Intervention: cetuximab
1
Radiotherapy 70Gy, Erbitux, Carboplatin-5FU
Intervention: Carboplatin, 5FU concomitant
1
Radiotherapy 70Gy, Erbitux, Carboplatin-5FU
Intervention: Radiotherapy
2
Radiotherapy 70Gy, Erbitux
Intervention: cetuximab
2
Radiotherapy 70Gy, Erbitux
Intervention: Radiotherapy
Outcomes
Primary Outcomes
Progression free survival
Time Frame: 3 years
Secondary Outcomes
- Loco-regional control(3 years)
Study Sites (5)
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