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

Phase 1

Completed

• Conditions: Head and Neck Neoplasms
• Interventions: Procedure: FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).

• Registration Number: NCT00135161
• Lead Sponsor: University Hospital, Ghent

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-08-24
• Study First Submitted QC: 2005-08-24
• Study First Posted: 2005-08-25
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intensity modulated radiation therapy (IMRT).	FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).	-

Primary Outcome Measures

Name	Time	Method
Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy	until 3 months after the end of the radiotherapy
Observation of chronic toxicity	until 3 months after the end of the radiotherapy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium