Back to resultsPhase I Trial From GRID 18F-FDG-PET Biological Imaging-guided Intensitymodulated Radiotherapy (BG-IMRT) With Patients With Recurrent or New Head or Neck Tumor in Previously Radiated Area
Primary Purpose
Head and Neck Tumors
Status
Terminated
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
GRID radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Tumors focused on measuring Recurrent head and neck tumors
Eligibility Criteria
Inclusion Criteria:
- Recurrent or new head or neck tumor
- 18 years or older
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
GRID-radiotherapy followed by biological imaging guided IMRT
Outcomes
Primary Outcome Measures
Maximum tolerated dose.
Superior local control with Grid 18F-FDG-PET BG-IMRT using previously obtained maximum tolerated dose.
Secondary Outcome Measures
Full Information
NCT ID
NCT00528294
First Posted
September 11, 2007
Last Updated
December 15, 2022
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00528294
Brief Title
Phase I Trial From GRID 18F-FDG-PET Biological Imaging-guided Intensitymodulated Radiotherapy (BG-IMRT) With Patients With Recurrent or New Head or Neck Tumor in Previously Radiated Area
Official Title
Phase I Trial From GRID 18F-FDG-PET Biological Imaging-guided Intensitymodulated Radiotherapy (BG-IMRT) With Patients With Recurrent or New Head or Neck Tumor in Previously Radiated Area
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Study status unknown Investigator retired and no longer working in the institution.
Study Start Date
February 2007 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trials examines the feasibility of GRID-therapy combined with biologically imaging based IMRT (BG-IMRT). Within this trial, the strict toxicity parameters of primary treatment of head and neck tumors are used. The GRID and BG-IMRT technique might be possible to reduce the total radiation dose 2 to 3 times.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Tumors
Keywords
Recurrent head and neck tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
GRID-radiotherapy followed by biological imaging guided IMRT
Intervention Type
Radiation
Intervention Name(s)
GRID radiotherapy
Intervention Description
GRID-radiotherapy followed by biological imaging guided IMRT
Primary Outcome Measure Information:
Title
Maximum tolerated dose.
Time Frame
3 months after end of treatment
Title
Superior local control with Grid 18F-FDG-PET BG-IMRT using previously obtained maximum tolerated dose.
Time Frame
1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recurrent or new head or neck tumor
18 years or older
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 University Hospital Ghent
Learn more about this trial
Phase I Trial From GRID 18F-FDG-PET Biological Imaging-guided Intensitymodulated Radiotherapy (BG-IMRT) With Patients With Recurrent or New Head or Neck Tumor in Previously Radiated Area
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