Trial Information
Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study
Inclusion Criteria:
- Oral and oropharynx (exclusion vallecula) squamous cell carcinoma
- T1 or T2
- unique, untreated tumor
- N0 or nodes <3cm
- complete pathological resection
- no perineural spread, vascular emboli <5
- pN0 or <=2N+R-
- signed inform consent
Exclusion Criteria:
- Vallecula carcinoma
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
loco-regional control
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Stephane Temam
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
France: Ministry of Health
Study ID:
Marges-ORL
NCT ID:
NCT00232960
Start Date:
October 2005
Completion Date:
June 2014
Related Keywords:
- Oral Cancer
- Oropharynx Cancer
- oral and oropharynx carcinoma
- surgery
- postoperative radiotherapy
- molecular analysis
- microsatellite instability
- Carcinoma, Squamous Cell
- Mouth Neoplasms
- Oropharyngeal Neoplasms