Radiotherapy in Association With Cetuximab in Patients Treated for an Epidermoid Cancer

Prospective Study About the Association of Radiotherapy and Cetuximab in the Treatment of Epidermoid Cancers, Locally Advanced, of the Head and Neck.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01647555

Enrollment

Registered

2012-07-23

Start date

2006-10-06

Completion date

2014-10-01

Last updated

2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidermoid Head and Neck Cancer

Keywords

Cetuximab, radiotherapy, epidermoid head and neck cancer

Brief summary

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

Detailed description

This prospective and multicentric study evaluates the skin toxicities in patients with locally Advanced head and neck epidermoid cancer, treated by Radiotherapy in association with Cetuximab.

Interventions

DRUGCetuximab

First cycle: 400 mg/m2 Next cycles: 250 mg/m2

RADIATIONRadiotherapy

Curative dose: 66 to 70 Gy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Skin toxicities	until week 38	according to NCI-CTCAE version 3.0

Secondary

Measure	Time frame	Description
Healthcare and evolution of skin toxicities	until week 38	Treatment of skin toxicities, according to sponsor advices.
Quality of life reporting	baseline, week 4, month 6	Questionnaire QLQ-C30
tumoral efficacy	6 months after treatment	According to RECIST criteria

Countries

France

Contacts

STUDY_DIRECTOREric LARTIGAU, MD, PhD

Oscar Lambret Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026