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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Groupe d'Etude des Tumeurs de la Tête Et du Cou
Information provided by (Responsible Party):
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00232960
First received: October 4, 2005
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer Oral Cancer
U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • loco-regional control [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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

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

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
Institut Gustave Roussy
Groupe d'Etude des Tumeurs de la Tête Et du Cou
Investigators
Principal Investigator: Stephane Temam Institut Gustave Roussy
  More Information

No publications provided

Responsible Party: Institut Gustave Roussy
ClinicalTrials.gov Identifier: NCT00232960     History of Changes
Other Study ID Numbers: Marges-ORL
Study First Received: October 4, 2005
Last Updated: March 27, 2012
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Mouth Neoplasms
Oropharyngeal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013