Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Centre Oscar Lambret Identifier:
First received: July 19, 2012
Last updated: August 22, 2014
Last verified: August 2014

July 19, 2012
August 22, 2014
November 2006
May 2012   (final data collection date for primary outcome measure)
Skin toxicities [ Time Frame: until week 38 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    Treatment of skin toxicities, according to sponsor advices.
  • Quality of life [ Time Frame: baseline, week 4, month 6 ] [ Designated as safety issue: No ]
    Questionnaire QLQ-C30
  • tumoral efficacy [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    According to RECIST criteria
Same as current
Not Provided
Not Provided
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.

Not Provided
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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.
Active, not recruiting
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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Centre Oscar Lambret
Centre Oscar Lambret
Not Provided
Study Director: Eric LARTIGAU, MD PhD Oscar Lambret Center
Centre Oscar Lambret
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP