Chemoradiotherapy HNSCC, Randomized Study, Docetaxel,Cisplatin, 5FU,Erbitux.
This trial is active, not recruiting.
|Condition||squamous cell head and neck carcinoma|
|Treatments||carboplatin, 5 fluorouracil, radiation therapy|
|Sponsor||Groupe Oncologie Radiotherapie Tete et Cou|
|Start date||May 2009|
|End date||February 2016|
|Trial size||370 participants|
|Trial identifier||NCT01233843, GORTEC 2007-02|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Complete response rate of the treatment
time frame: by CT scan or MRI and endoscopy 2 years after the end of treatment
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.
time frame: Date of death
Male or female participants from 18 years up to 70 years old.
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
|Official title||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|
|Principal investigator||Etienne BARDET, oncologist|
|Description||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 .|
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