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

This study is currently recruiting participants.
Verified July 2012 by Centre Oscar Lambret
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01647555
First received: July 19, 2012
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention
Epidermoid Head and Neck Cancer
Drug: Cetuximab
Radiation: Radiotherapy

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Skin toxicities [ Time Frame: until week 38 ] [ Designated as safety issue: No ]
    according to NCI-CTCAE version 3.0


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: November 2006
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient with epidermoid head and neck cancer locally advanced

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647555

Contacts
Contact: Eric LARTIGAU, MDPhD +33 (0)3.20.29.59.18 e-lartigau@o-lambret.fr

Locations
France
Clinique du Parc Recruiting
Croix, France, 599962
Contact: Michel FINCK, MD    08 26.66 69 00      
Contact: Renata FEREIRA, MD         
Centre Leonard de Vinci Recruiting
Douai, France, 59500
Contact: Damien CARLIER    03 27 08 60 61    damien.carlier@clinique-psv-douai.fr   
Sub-Investigator: Marc TOKARSKI, MD         
Sub-Investigator: Franck DARLOY, MD         
Centre Bourgogne Recruiting
Lille, France, 59000
Contact: Florence SCHRAM, MD         
Centre Galilée Recruiting
Lille, France, 59045
Contact: David PASQUIER, MD    03.28.53.53.52    d-pasquier@o-lambret.fr   
Sub-Investigator: Honorine KOUTO, MD         
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Eric LARTIGAU, PhD    0320295918    e-lartigau@o-lambret.fr   
Contact: Bernard CASTELAIN, MD         
Sub-Investigator: Bernard COCHE DEQUEANT, MD         
Sub-Investigator: David PASQUIER, MD         
Sub-Investigator: Marian DEGARDIN, MD         
Centre Gray Recruiting
Maubeuge, France, 59600
Contact: Pascal MEYER, MD    03.27.69.83.83    Meyer.Pascal@wanadoo.fr   
Centre Joliot Curie Recruiting
Saint Martin Les Boulogne, France, 62280
Contact: Jacques HERNANDEZ, MD         
Sub-Investigator: Jean Christophe CHARDON, MD         
Sub-Investigator: Françoise HOHNADEL, MD         
Sub-Investigator: Laurent GASNAULT, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Study Director: Eric LARTIGAU, MD PhD Oscar Lambret Center
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01647555     History of Changes
Other Study ID Numbers: ESPACE
Study First Received: July 19, 2012
Last Updated: July 20, 2012
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés

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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014