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

Epidermoid Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01647555
• Other study ID #: ESPACE
• Status: Active, not recruiting
• Phase: N/A
• First received: July 19, 2012
• Last updated: August 22, 2014
• Start date: November 2006
• Est. completion date: December 2014

Study information

• Verified date: August 2014
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: December 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epidermoid Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Cetuximab
First cycle: 400 mg/m2 Next cycles: 250 mg/m2

Radiation:
• Radiotherapy
Curative dose: 66 to 70 Gy

Locations

Country	Name	City	State
France	Clinique du Parc	Croix
France	Centre Leonard de Vinci	Douai
France	Centre Bourgogne	Lille
France	Centre Galilée	Lille
France	Centre Oscar Lambret	Lille
France	Centre Gray	Maubeuge
France	Centre Joliot Curie	Saint Martin Les Boulogne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin toxicities	according to NCI-CTCAE version 3.0	until week 38	No
Secondary	Healthcare and evolution of skin toxicities	Treatment of skin toxicities, according to sponsor advices.	until week 38	No
Secondary	Quality of life	Questionnaire QLQ-C30	baseline, week 4, month 6	No
Secondary	tumoral efficacy	According to RECIST criteria	6 months after treatment	No