Trial | NCT01233843  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    370
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.
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 .
Study Started
May 18
2009
Primary Completion
Nov 06
2018
Study Completion
Nov 06
2018
Last Update
Jan 18
2019

Drug carboplatin

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

Drug 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

Drug and radiation 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.

drug and radiation 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).

Criteria 

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
No Results Posted