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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01233843

Acronym

2007/02

Enrollment

370

Registered

2010-11-03

Start date

2009-05-18

Completion date

2018-11-06

Last updated

2019-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Head and Neck Carcinoma

Keywords

induction chemotherapy, followed by irradiation and concurrent Erbitux, or radiochemotherapy

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 .

Interventions

DRUGcarboplatin

70 mg per m2 and per day for four days. day 1; day 22; day 43

DRUG5 fluorouracil

600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43

RADIATIONradiation therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026