Overview

This trial is active, not recruiting.

Conditions oral cancer, oropharynx cancer
Treatment radiotherapy 50 gy
Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Collaborator Groupe d'Etude des Tumeurs de la Tête Et du Cou
Start date October 2005
End date June 2014
Trial size 310 participants
Trial identifier NCT00232960, Marges-ORL

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
loco-regional control
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study
Principal investigator Stephane Temam
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Gustave Roussy, Cancer Campus, Grand Paris.