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

Oral Cancer Clinical Trial

Official title:

Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00232960
• Other study ID #: Marges-ORL
• Status: Active, not recruiting
• Phase: N/A
• First received: October 4, 2005
• Last updated: March 27, 2012
• Start date: October 2005
• Est. completion date: June 2014

Study information

• Verified date: March 2012
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 310
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oral Cancer
• Oropharynx Cancer

Intervention

Procedure:
• Radiotherapy 50 Gy

Locations

Country	Name	City	State
France	Centre Francois Baclesse	Caen
France	Hôpital de la Croix Rousse	Lyon
France	Centre Alexis Vautrin	Vandoeuvre les Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris	Groupe d'Etude des Tumeurs de la Tête Et du Cou

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	loco-regional control		5 years	No