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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01647555
First received: July 19, 2012
Last updated: August 22, 2014
Last verified: August 2014
  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


Enrollment: 57
Study Start Date: November 2006
Estimated Study Completion Date: December 2014
Primary Completion Date: May 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Clinique du Parc
Croix, France, 599962
Centre Leonard de Vinci
Douai, France, 59500
Centre Bourgogne
Lille, France, 59000
Centre Galilée
Lille, France, 59045
Centre Oscar Lambret
Lille, France, 59020
Centre Gray
Maubeuge, France, 59600
Centre Joliot Curie
Saint Martin Les Boulogne, France, 62280
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: August 22, 2014
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 October 01, 2014