Chemoradiotherapy HNSCC, Randomized Study, Docetaxel,Cisplatin, 5FU,Erbitux.

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that induction chemotherapy followed by radiation therapy plus Cetuximab will give better results than the validated treatment (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers.

Detailed Description
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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 .

Official Title
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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

Conditions
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Squamous Cell Head and Neck Carcinoma

Intervention / Treatment
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* Drug: carboplatin
* Drug: 5 fluorouracil
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Drug and radiation<br>Radiotherapy : 70 grays , fractionization : 2Gy/day, 5 days / week, for 7 weeks . Concurrent administration of Carboplatin: 70 mg/m2/day (day 1 until day 4)and 5FU 600 mg/m2/day (day 1 until day 4). Weeks 1; 4; 7. | Drug: carboplatin<br>* 70 mg per m2 and per day for four days. day 1; day 22; day 43<br>Drug: 5 fluorouracil<br>* 600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43<br>Radiation: radiation therapy<br>* total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks<br>|
| Experimental: drug and radiation<br>Induction chemotherapy by Docetaxel 100mg/m2, day 1; cisplatin 100mg/m2, day 1; 5-Fluorouracil 1000mg/m2 (from day 1 to day 5), for a total of three cycles .Those cycles are administrated at day 1; day 22, day43. This induction chemotherapy is followed ( for responders or stable disease patients)by radiotherapy (70 grays for 7 weeks) and concurrent Erbitux( weekly administration). | Drug: carboplatin<br>* 70 mg per m2 and per day for four days. day 1; day 22; day 43<br>Drug: 5 fluorouracil<br>* 600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43<br>Radiation: radiation therapy<br>* total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate of the treatment | measure of the tumor | by CT scan or MRI and endoscopy 2 years after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The second focus of this study is to compare Overall survival between the two arms . It is defined as the time from the date of randomization to the date of death from any cause. | Aftercare every six months | Date of death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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induction chemotherapy, followed by irradiation and concurrent Erbitux, or radiochemotherapy