Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC

Gustave Roussy

Status: Unknown

Conditions: Oropharynx Cancer; Oral Cancer

Treatments: Procedure: Radiotherapy 50 Gy

Study type: Interventional

Funder types: Other

Identifiers

NCT00232960

Marges-ORL

Details and patient eligibility

About

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.

Enrollment: 310 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)