Back to resultsPostoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC
Primary Purpose
Oral Cancer, Oropharynx Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiotherapy 50 Gy
Sponsored by
About this trial
This is an interventional treatment trial for Oral Cancer focused on measuring oral and oropharynx carcinoma, surgery, postoperative radiotherapy, molecular analysis, microsatellite instability
Eligibility 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
Sites / Locations
- Centre Francois Baclesse
- Hôpital de la Croix Rousse
- Centre Alexis Vautrin
- Institut Gustave Roussy
Outcomes
Primary Outcome Measures
loco-regional control
Secondary Outcome Measures
Full Information
NCT ID
NCT00232960
First Posted
October 4, 2005
Last Updated
March 27, 2012
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Tumor Study Group Head and Neck
1. Study Identification
Unique Protocol Identification Number
NCT00232960
Brief Title
Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC
Official Title
Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Tumor Study Group Head and Neck
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer, Oropharynx Cancer
Keywords
oral and oropharynx carcinoma, surgery, postoperative radiotherapy, molecular analysis, microsatellite instability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
310 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Radiotherapy 50 Gy
Primary Outcome Measure Information:
Title
loco-regional control
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane Temam
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Hôpital de la Croix Rousse
City
Lyon
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
12. IPD Sharing Statement
Learn more about this trial
Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC
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