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Completed

NCT Number: NCT00135161

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

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

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Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Primary outcomes

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

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

  2. Observation of chronic toxicity

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

Secondary outcomes

  1. Therapy response (2-4 months after end of radiotherapy)

    Time frame: 2-4 months after end of radiotherapy

  2. Local control at 2 years

    Time frame: at 2 years

  3. Pattern of recurrence

    Time frame: at 2 years

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Belgian Federation Against Cancer

Registry information

Important dates

Study start
2003
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2005
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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