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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00232960
First Posted: October 5, 2005
Last Update Posted: March 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Groupe d'Etude des Tumeurs de la Tête Et du Cou
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • loco-regional control [ Time Frame: 5 years ]

Enrollment: 310
Study Start Date: October 2005
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232960


Locations
France
Centre Francois Baclesse
Caen, France, 14000
Hôpital de la Croix Rousse
Lyon, France
Centre Alexis Vautrin
Vandoeuvre les Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Groupe d'Etude des Tumeurs de la Tête Et du Cou
Investigators
Principal Investigator: Stephane Temam Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT00232960     History of Changes
Other Study ID Numbers: Marges-ORL
First Submitted: October 4, 2005
First Posted: October 5, 2005
Last Update Posted: March 28, 2012
Last Verified: March 2012

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
oral and oropharynx carcinoma
surgery
postoperative radiotherapy
molecular analysis
microsatellite instability

Additional relevant MeSH terms:
Mouth Neoplasms
Oropharyngeal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases