NCT01237483

Reirradiation and Erbitux in the HNSCC

A Phase II Study, Multicenter, to Evaluate the Efficacy and Safety of the Combination of Reirradiation - Erbitux in Subjects Previously Irradiated and With a Local Recurrent Inoperable Squamous Cell Cancer of the Head and Neck

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate in patients with cancer of the throat and recurrent inoperable a different modality treatment consisting of radiation continuously for 5 weeks and half associated with a drug directed against a receptor on cell surfaces cancer, called Erbitux ®. The investigators hope with this shorter treatment (1.5 weeks less than the usual treatment) to improve the antitumor efficacy without additional toxic side effects.

Detailed description

We hope with this treatment improved antitumor efficacy without additional toxic side effects, while being shorter than 1.5 weeks of standard therapy. But this is an hypothesis we can not meet the current state of knowledge, which justifies this study. The main hypothesis is that this combination of reirradiation and Cetuximab give a relative gain of 15% complete response rate.

Conditions

• Head and Neck Cancer Squamous Cell

Interventions

Type	Name	Description
DRUG	Erbitux	To begin 7 days before radiotherapy, loading dose 400 mg / m² in the first week then 250 mg / m² weekly for the duration of radiotherapy (for a total of 7 doses including the loading dose)

Timeline

• Start date: 2010-10-01
• Primary completion: 2016-07-01
• Completion: 2016-07-05
• First posted: 2010-11-09
• Last updated: 2017-10-26

Locations

1 site across 1 country: France