Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer
18 Years
N/A
Both
Head and Neck Neoplasms
Trial Information
Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer
The dose escalation, based on the FDG-PET signal, is incorporated in the first ten fractions
of the radiotherapeutic treatment. The total amount of fractions is 32, equal to a standard
radiotherapeutic treatment for these types of cancers.
Inclusion Criteria:
- Patients with a proven histological squamous cell carcinoma of the 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 in this trial
Exclusion Criteria:
- Other malignancy except for non-melanoma skin cancer
- Prior irradiation to the head and neck region
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy
Outcome Time Frame:
until 3 months after the end of the radiotherapy
Safety Issue:
No
Principal Investigator
Wilfried De Neve, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Ghent
Authority:
Belgium: Institutional Review Board
Study ID:
2003/202
NCT ID:
NCT00135161
Start Date:
September 2003
Completion Date:
August 2013
Related Keywords:
- Head and Neck Neoplasms
- neoplasms (squamous cell carcinoma of the head and neck region)
- Neoplasms
- Head and Neck Neoplasms
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