Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC
- Conditions
- Oral CancerOropharynx Cancer
- Registration Number
- NCT00232960
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Brief Summary
There is no consensus on the indication of postoperative radiotherapy for early stages oral and oropharyngeal squamous cell carcinoma with complete pathological resection and no neck node metastasis, but most of the institutions do not give any post-operative treatment. Loco-regional control rates range between 80-85% at five years. Surgical margins molecular analysis for microsatellite instability (MSI) marker could help to select the high-risk patients who should receive postoperative radiotherapy. We expect to include 120 patients in five years and have 60 informative tumors for MSI marker. Patients with positive molecular margins will receive postoperative radiotherapy (50 Gy). Patients with negative molecular margins will not receive radiotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 310
- 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
- Vallecula carcinoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method loco-regional control 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Hôpital de la Croix Rousse
🇫🇷Lyon, France
Centre Francois Baclesse
🇫🇷Caen, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre les Nancy, France
Institut Gustave Roussy
🇫🇷Villejuif, France