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Completed

NCT Number: NCT01233843

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

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.

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Key information

Conditions

Squamous Cell Head and Neck Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GIRARD CALAIS Marie-Helene

Tours, 37044, France

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carboplatin

Drug

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

5 fluorouracil

Drug

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

radiation therapy

Radiation

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

Primary outcomes

  1. Complete response rate of the treatment

    Time frame: by CT scan or MRI and endoscopy 2 years after the end of treatment

    measure of the tumor

Secondary outcomes

  1. 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

    Aftercare every six months

Sponsors and collaborators

Lead sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Other

Registry information

Official study 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

Acronym: 2007/02

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Nov 3, 2010
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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