Back to resultsTrial of Adaptive 18F-FDG-PET Biological Intensity-modulated Radiotherapy (BG-IMRT) in Patients With Head and Neck Tumor
Primary Purpose
Head and Neck Tumor
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
18F-FDG-PET radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Tumor
Eligibility Criteria
Inclusion Criteria:
- Head and neck tumor
- Aged > 18 years
Sites / Locations
- University Hospital Ghent
Outcomes
Primary Outcome Measures
Tumor recurrences
Secondary Outcome Measures
Full Information
NCT ID
NCT00406289
First Posted
November 30, 2006
Last Updated
September 3, 2010
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00406289
Brief Title
Trial of Adaptive 18F-FDG-PET Biological Intensity-modulated Radiotherapy (BG-IMRT) in Patients With Head and Neck Tumor
Official Title
Phase I Trial of Adaptive 18F-FDG-PET Biological Intensity-modulated Radiotherapy (BG-IMRT) With Patients With Head and Neck Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the feasibility of higher and prolonged dose escalation concentrated in the intra-tumoral regions which are FDG-avid after two weeks of radiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
18F-FDG-PET radiotherapy
Primary Outcome Measure Information:
Title
Tumor recurrences
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Head and neck tumor
Aged > 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried De Neve, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Trial of Adaptive 18F-FDG-PET Biological Intensity-modulated Radiotherapy (BG-IMRT) in Patients With Head and Neck Tumor
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