Overview

This trial is active, not recruiting.

Condition squamous cell head and neck carcinoma
Treatments carboplatin, 5 fluorouracil, radiation therapy
Phase phase 3
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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.
carboplatin carboplatin
70 mg per m2 and per day for four days. day 1; day 22; day 43
5 fluorouracil 5 Fluorouracil
600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43
radiation therapy
total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks
(Experimental)
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).
carboplatin carboplatin
70 mg per m2 and per day for four days. day 1; day 22; day 43
5 fluorouracil 5 Fluorouracil
600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43
radiation therapy
total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks

Primary Outcomes

Measure
Complete response rate of the treatment
time frame: by CT scan or MRI and endoscopy 2 years after the end of treatment

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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 .
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Groupe Oncologie Radiotherapie Tete et Cou.