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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

October 4, 2005
March 27, 2012
October 2005
June 2014   (final data collection date for primary outcome measure)
loco-regional control [ Time Frame: 5 years ] [ Designated as safety issue: No ]
loco-regional control
Complete list of historical versions of study NCT00232960 on ClinicalTrials.gov Archive Site
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Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC
Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study

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.
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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Oral Cancer
  • Oropharynx Cancer
Procedure: Radiotherapy 50 Gy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
310
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00232960
Marges-ORL
Not Provided
Institut Gustave Roussy
Institut Gustave Roussy
Groupe d'Etude des Tumeurs de la Tête Et du Cou
Principal Investigator: Stephane Temam Institut Gustave Roussy
Institut Gustave Roussy
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP