Chemoradiotherapy HNSCC, Randomized Study, Docetaxel,Cisplatin, 5FU,Erbitux. (2007/02)

Groupe Oncologie Radiotherapie Tete et Cou

Status and phase: Completed; Phase 3

Conditions: Squamous Cell Head and Neck Carcinoma

Treatments: Drug: 5 fluorouracil; Radiation: radiation therapy; Drug: carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01233843

GORTEC 2007-02

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 370 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

370 participants in 2 patient groups

Drug and radiation

Other group

Description:

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.

Treatment:

Drug: 5 fluorouracil

Radiation: radiation therapy

Drug: carboplatin

drug and radiation

Experimental group

Description:

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).

Treatment:

Drug: 5 fluorouracil

Radiation: radiation therapy

Drug: carboplatin