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

NCT ID: NCT01647555

Last Updated: 2014-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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Conditions

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Epidermoid Head and Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patient with epidermoid cancer

receiving Cetuximab and radiotherapy

Cetuximab

Intervention Type DRUG

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

Radiotherapy

Intervention Type RADIATION

Curative dose: 66 to 70 Gy

Interventions

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Cetuximab

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

Intervention Type DRUG

Radiotherapy

Curative dose: 66 to 70 Gy

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Oscar Lambret

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric LARTIGAU, MD PhD

Role: STUDY_DIRECTOR

Oscar Lambret Center

Locations

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Clinique du Parc

Croix, , France

Site Status

Centre Leonard de Vinci

Douai, , France

Site Status

Centre Bourgogne

Lille, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Centre Galilée

Lille, , France

Site Status

Centre Gray

Maubeuge, , France

Site Status

Centre Joliot Curie

Saint Martin Les Boulogne, , France

Site Status

Countries

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France

Other Identifiers

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ESPACE

Identifier Type: -

Identifier Source: org_study_id

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