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NCT00135161 Clinical Trial

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

Head and Neck Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00135161
Other study ID # 2003/202
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2003
Est. completion date August 2015

Study information
Verified date December 2022
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent Belgian Federation Against Cancer

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy until 3 months after the end of the radiotherapy
Primary Observation of chronic toxicity until 3 months after the end of the radiotherapy
Secondary Therapy response (2-4 months after end of radiotherapy) 2-4 months after end of radiotherapy
Secondary Local control at 2 years at 2 years
Secondary Pattern of recurrence at 2 years
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