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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01647555
Recruitment Status : Unknown
Verified August 2014 by Centre Oscar Lambret.
Recruitment status was:  Active, not recruiting
First Posted : July 23, 2012
Last Update Posted : August 25, 2014
Information provided by (Responsible Party):
Centre Oscar Lambret

July 19, 2012
July 23, 2012
August 25, 2014
November 2006
May 2012   (Final data collection date for primary outcome measure)
Skin toxicities [ Time Frame: until week 38 ]
according to NCI-CTCAE version 3.0
Same as current
Complete list of historical versions of study NCT01647555 on Archive Site
  • Healthcare and evolution of skin toxicities [ Time Frame: until week 38 ]
    Treatment of skin toxicities, according to sponsor advices.
  • Quality of life [ Time Frame: baseline, week 4, month 6 ]
    Questionnaire QLQ-C30
  • tumoral efficacy [ Time Frame: 6 months after treatment ]
    According to RECIST criteria
Same as current
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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.
This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.
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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patient with epidermoid head and neck cancer locally advanced
Epidermoid Head and Neck Cancer
  • Drug: Cetuximab
    First cycle: 400 mg/m2 Next cycles: 250 mg/m2
  • Radiation: Radiotherapy
    Curative dose: 66 to 70 Gy
patient with epidermoid cancer
receiving Cetuximab and radiotherapy
  • Drug: Cetuximab
  • Radiation: Radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
December 2014
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Centre Oscar Lambret
Centre Oscar Lambret
Not Provided
Study Director: Eric LARTIGAU, MD PhD Oscar Lambret Center
Centre Oscar Lambret
August 2014