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

Phase 3

Completed

• Conditions: Squamous Cell Head and Neck Carcinoma
• Interventions: Drug: carboplatin; Drug: 5 fluorouracil; Radiation: radiation therapy

• Registration Number: NCT01233843
• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

Brief Summary

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

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 .

Study Timeline

• Study Start: 2009-05-18
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Primary Completion: 2018-11-06
• Study Completion: 2018-11-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

• head and neck locally advanced,non metastatic carcinoma
• not suitable for surgery

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Exclusion Criteria

• non squamous cell head and neck cancer
• previous malignancy
• previous treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug and radiation	5 fluorouracil	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 and radiation	radiation therapy	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 and radiation	radiation therapy	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 and radiation	5 fluorouracil	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 and radiation	carboplatin	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 and radiation	carboplatin	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).

Primary Outcome Measures

Name	Time	Method
Complete response rate of the treatment	by CT scan or MRI and endoscopy 2 years after the end of treatment	measure of the tumor

Secondary Outcome Measures

Name	Time	Method
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.	Date of death	Aftercare every six months

Trial Locations

Locations (1)

GIRARD CALAIS Marie-Helene; 🇫🇷 Tours, France