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Completed

NCT Number: NCT01647555

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

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

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Key information

Conditions

Epidermoid Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique du Parc, Croix, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetuximab

Drug

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

Radiotherapy

Radiation

Curative dose: 66 to 70 Gy

Primary outcomes

  1. Skin toxicities

    Time frame: until week 38

    according to NCI-CTCAE version 3.0

Secondary outcomes

  1. Healthcare and evolution of skin toxicities

    Time frame: until week 38

    Treatment of skin toxicities, according to sponsor advices.

  2. Quality of life reporting

    Time frame: baseline, week 4, month 6

    Questionnaire QLQ-C30

  3. tumoral efficacy

    Time frame: 6 months after treatment

    According to RECIST criteria

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2012
Study completion
2014
First posted
Jul 23, 2012
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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