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.
1 other identifier
observational
57
1 country
7
Brief Summary
This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2006
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 6, 2006
CompletedFirst Submitted
Initial submission to the registry
July 19, 2012
CompletedFirst Posted
Study publicly available on registry
July 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedMarch 18, 2026
September 1, 2020
6 years
July 19, 2012
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Skin toxicities
according to NCI-CTCAE version 3.0
until week 38
Secondary Outcomes (3)
Healthcare and evolution of skin toxicities
until week 38
Quality of life reporting
baseline, week 4, month 6
tumoral efficacy
6 months after treatment
Study Arms (1)
patient with epidermoid cancer
receiving Cetuximab and radiotherapy
Interventions
Eligibility Criteria
Patient with epidermoid head and neck cancer locally advanced
You may qualify if:
- 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)
You may not qualify if:
- other histology
- Metastatic disease
- Recurrent patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Clinique du Parc
Croix, 599962, France
Centre Leonard de Vinci
Douai, 59500, France
Centre Bourgogne
Lille, 59000, France
Centre Oscar Lambret
Lille, 59020, France
Centre Galilée
Lille, 59045, France
Centre Gray
Maubeuge, 59600, France
Centre Joliot Curie
Saint-Martin-Boulogne, 62280, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eric LARTIGAU, MD, PhD
Oscar Lambret Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2012
First Posted
July 23, 2012
Study Start
October 6, 2006
Primary Completion
October 1, 2012
Study Completion
October 1, 2014
Last Updated
March 18, 2026
Record last verified: 2020-09