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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 1

Conditions: Head and Neck Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00135161

2003/202

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Intensity modulated radiation therapy (IMRT).

Experimental group

Treatment:

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