Overview

This trial is active, not recruiting.

Condition epidermoid head and neck cancer
Treatments cetuximab, radiotherapy
Target EGFR
Sponsor Centre Oscar Lambret
Start date November 2006
End date May 2012
Trial size 57 participants
Trial identifier NCT01647555, ESPACE

Summary

This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
receiving Cetuximab and radiotherapy
cetuximab
First cycle: 400 mg/m2 Next cycles: 250 mg/m2
radiotherapy
Curative dose: 66 to 70 Gy

Primary Outcomes

Measure
Skin toxicities
time frame: until week 38

Secondary Outcomes

Measure
Healthcare and evolution of skin toxicities
time frame: until week 38
Quality of life
time frame: baseline, week 4, month 6
tumoral efficacy
time frame: 6 months after treatment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age > 18 years - Epidermoid head and neck carcinoma locally advanced - Indication of Cetuximab and radiotherapy - Karnofsky >= 60 - Patients participating to another compatible study could be included after consultation with the study director Patients could be beforehand treated for an other ORL cancer The radiotherapy will be delivered for curative aim (minimal dose 66 Gy) Exclusion Criteria: - other histology - Metastatic disease - Recurrent patients

Additional Information

Official title Prospective Study About the Association of Radiotherapy and Cetuximab in the Treatment of Epidermoid Cancers, Locally Advanced, of the Head and Neck.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Centre Oscar Lambret.