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

August 22, 2014 updated by: Centre Oscar Lambret

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Croix, France, 599962
        • Clinique du Parc
      • Douai, France, 59500
        • Centre Leonard de Vinci
      • Lille, France, 59020
        • Centre OSCAR LAMBRET
      • Lille, France, 59000
        • Centre Bourgogne
      • Lille, France, 59045
        • Centre Galilée
      • Maubeuge, France, 59600
        • Centre Gray
      • Saint Martin Les Boulogne, France, 62280
        • Centre Joliot Curie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with epidermoid head and neck cancer locally advanced

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patient with epidermoid cancer
receiving Cetuximab and radiotherapy
Drug: Cetuximab
First cycle: 400 mg/m2 Next cycles: 250 mg/m2
Radiation: Radiotherapy
Curative dose: 66 to 70 Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin toxicities
Time Frame: until week 38
according to NCI-CTCAE version 3.0
until week 38

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Study Director: Eric LARTIGAU, MD PhD, Oscar Lambret Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

May 1, 2012

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

July 20, 2012

First Posted (Estimate)

July 23, 2012

Study Record Updates

Last Update Posted (Estimate)

August 25, 2014

Last Update Submitted That Met QC Criteria

August 22, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESPaCe

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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