|
|
|
|
|
|
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 |
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 |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stéphane Temam | 33 1 42 11 46 17 | temam@igr.fr |
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 |
Institut Gustave Roussy |
Groupe d'Etude des Tumeurs de la Tête Et du Cou |
Principal Investigator: | Stephane Temam | Institut Gustave Roussy |
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 |
|
|
|
|