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

December 6, 2022 updated by: University Hospital, Ghent
The purpose of this trial is to study fluorodeoxyglucose-positron emission tomography (FDG-PET)-based dose escalation using intensity modulated radiation therapy (IMRT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensity modulated radiation therapy (IMRT).
Procedure: FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).
FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy
Time Frame: until 3 months after the end of the radiotherapy
until 3 months after the end of the radiotherapy
Observation of chronic toxicity
Time Frame: until 3 months after the end of the radiotherapy
until 3 months after the end of the radiotherapy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Belgian Federation Against Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2003

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 24, 2005

First Submitted That Met QC Criteria

August 24, 2005

First Posted (Estimate)

August 25, 2005

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003/202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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