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

Squamous Cell Head and Neck Carcinoma Clinical Trial

— 2007/02  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233843
• Other study ID #: GORTEC 2007-02
• Status: Completed
• Phase: Phase 3
• Start date: May 18, 2009
• Est. completion date: November 6, 2018

Study information

• Verified date: January 2019
• Source: Groupe Oncologie Radiotherapie Tete et Cou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: November 6, 2018
• Est. primary completion date: November 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Squamous Cell Head and Neck Carcinoma

Intervention

Drug:
• carboplatin
70 mg per m2 and per day for four days. day 1; day 22; day 43
• 5 fluorouracil
600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43

Radiation:
• radiation therapy
total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks

Locations

Country	Name	City	State
France	GIRARD CALAIS Marie-Helene	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Oncologie Radiotherapie Tete et Cou

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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