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

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

Condition or disease Intervention/treatment
Epidermoid Head and Neck Cancer Drug: Cetuximab Radiation: Radiotherapy

Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study About the Association of Radiotherapy and Cetuximab in the Treatment of Epidermoid Cancers, Locally Advanced, of the Head and Neck.
Study Start Date : November 2006
Actual Primary Completion Date : May 2012
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Skin toxicities [ Time Frame: until week 38 ]
    according to NCI-CTCAE version 3.0

Secondary Outcome Measures :
  1. Healthcare and evolution of skin toxicities [ Time Frame: until week 38 ]
    Treatment of skin toxicities, according to sponsor advices.

  2. Quality of life [ Time Frame: baseline, week 4, month 6 ]
    Questionnaire QLQ-C30

  3. tumoral efficacy [ Time Frame: 6 months after treatment ]
    According to RECIST criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with epidermoid head and neck cancer locally advanced

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01647555

Clinique du Parc
Croix, France, 599962
Centre Leonard de Vinci
Douai, France, 59500
Centre Bourgogne
Lille, France, 59000
Centre Oscar Lambret
Lille, France, 59020
Centre Galilée
Lille, France, 59045
Centre Gray
Maubeuge, France, 59600
Centre Joliot Curie
Saint Martin Les Boulogne, France, 62280
Sponsors and Collaborators
Centre Oscar Lambret
Study Director: Eric LARTIGAU, MD PhD Oscar Lambret Center

Responsible Party: Centre Oscar Lambret Identifier: NCT01647555     History of Changes
Other Study ID Numbers: ESPACE
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: August 25, 2014
Last Verified: August 2014

Keywords provided by Centre Oscar Lambret:
epidermoid head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents