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

University Hospital, Ghent40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Neoplasms

Interventions

FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).PROCEDURE

FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Ghent

Ghent, Belgium

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

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

Data from ClinicalTrials.gov

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