Overview

This trial is active, not recruiting.

Condition head and neck neoplasms
Treatment fdg-pet-based dose escalation using intensity modulated radiation therapy (imrt).
Phase phase 1
Sponsor University Hospital, Ghent
Collaborator Belgian Federation Against Cancer
Start date September 2003
End date August 2015
Trial size 40 participants
Trial identifier NCT00135161, 2003/202

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
fdg-pet-based dose escalation using intensity modulated radiation therapy (imrt).
FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).

Primary Outcomes

Measure
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

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer
Principal investigator Wilfried De Neve, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.