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Pets and Pet Health |
Animal Health; Pets |
Clinical Trial: Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer
This study is no longer recruiting patients.
|
Purpose
FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).
| Condition | Intervention | Phase |
|---|---|---|
| neoplasms (squamous cell carcinoma of the head and neck region) | Procedure: FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT). | Phase I |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Further Study Details:
Primary Outcomes: Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy.; Observation of chronic toxicity.
Secondary Outcomes: Therapy response (2-4 months after end of radiotherapy); Local control at 2 years; Pattern of recurrence
Expected Total Enrollment: 40
Secondary Outcomes: Therapy response (2-4 months after end of radiotherapy); Local control at 2 years; Pattern of recurrence
Expected Total Enrollment: 40
Study start: September 2003
The dosis escalation, based on the FDG-PET signal, is incorporated in the first ten fractions of the radiotherapeutical treatment. The total amount of fractions is 32, equal to a standard radiotherapeutical treatment for these types of cancers.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- patients with a proven histological squamous cell carcinoma of larynx (only T3-4 NO or Tany N+) hypopharynx oropharynx
- patients who did not undergo surgery for the primary tumor location
- patients with a Karnofsky performance score of 70% or more
- written informed consent for participation to this trial
Exclusion Criteria:
- other malignancy except non-melanoma skin cancer
- prior irradiation to the head and neck region
Location Information
Belgium
University Hospital Ghent, Ghent, 9000, Belgium
Study chairs or principal investigators
Wilfried De Neve, MD, PhD, Principal Investigator, University Hospital Ghent
More Information
Website University Hospital Ghent
Study ID Numbers: 2003/202
Last Updated: September 9, 2005
Record first received: August 24, 2005
ClinicalTrials.gov Identifier: NCT00135161
Health Authority: Belgium: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 9, 2005
Record first received: August 24, 2005
ClinicalTrials.gov Identifier: NCT00135161
Health Authority: Belgium: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- "Don't Worry, They Won't Bite" (American Veterinary Medical Association)
- American Veterinary Medical Association
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