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

This study is currently recruiting participants.
Verified by Institut Gustave Roussy, September 2006

Sponsors and Collaborators: Institut Gustave Roussy
Groupe d'Etude des Tumeurs de la Tête Et du Cou
Information provided by: Institut Gustave Roussy
ClinicalTrials.gov Identifier: NCT00232960
  Purpose

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.


Condition Intervention
Oral Cancer
Oropharynx Cancer
Procedure: Radiotherapy 50 Gy

MedlinePlus related topics:   Cancer    Oral Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • loco-regional control

Estimated Enrollment:   120
Study Start Date:   October 2005

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232960

Contacts
Contact: Stéphane Temam     33 1 42 11 46 17     temam@igr.fr    

Locations
France
Institut Gustave Roussy     Recruiting
      Villejuif, France, 94800
      Contact: Stephane Temam     33 1 42 11 46 17     temam@igr.fr    
Centre Francois Baclesse     Not yet recruiting
      Caen, France, 14000
      Contact: Dominique De Raucourt            
Centre Alexis Vautrin     Not yet recruiting
      Vandoeuvre les Nancy, France, 54511
      Contact: Gilles Dolivet            
Hôpital de la Croix Rousse     Not yet recruiting
      Lyon, France
      Contact: M Poupart            

Sponsors and Collaborators
Institut Gustave Roussy
Groupe d'Etude des Tumeurs de la Tête Et du Cou

Investigators
Principal Investigator:     Stephane Temam     Institut Gustave Roussy    
  More Information


Study ID Numbers:   Marges-ORL
First Received:   October 4, 2005
Last Updated:   September 7, 2006
ClinicalTrials.gov Identifier:   NCT00232960
Health Authority:   France: Ministry of Health

Keywords provided by Institut Gustave Roussy:
oral and oropharynx carcinoma  
surgery  
postoperative radiotherapy  
molecular analysis  
microsatellite instability  

Study placed in the following topic categories:
Mouth Diseases
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Microsatellite Instability
Squamous cell carcinoma
Pharyngeal Neoplasms
Lip and oral cavity cancer
Mouth Neoplasms
Pharyngeal Diseases
Carcinoma
Epidermoid carcinoma
Oral cancer
Head and Neck Neoplasms
Carcinoma, squamous cell
Stomatognathic Diseases
Carcinoma, Squamous Cell
Oropharyngeal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 03, 2008




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