Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer

University Hospital, Ghent1 site in 1 country40 target enrollmentSeptember 2003

ConditionsHead and Neck Neoplasms

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Head and Neck Neoplasms
Sponsor: University Hospital, Ghent
Enrollment: 40
Locations: 1
Primary Endpoint: Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to study fluorodeoxyglucose-positron emission tomography (FDG-PET)-based dose escalation using intensity modulated radiation therapy (IMRT).

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

August 2015

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Ghent

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy

Time Frame: until 3 months after the end of the radiotherapy

Observation of chronic toxicity

Time Frame: until 3 months after the end of the radiotherapy

Secondary Outcomes

Local control at 2 years(at 2 years)
Therapy response (2-4 months after end of radiotherapy)(2-4 months after end of radiotherapy)
Pattern of recurrence(at 2 years)