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

Primary Purpose

Head and Neck Neoplasms

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring neoplasms (squamous cell carcinoma of the head and neck region)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intensity modulated radiation therapy (IMRT).

Arm Description

Outcomes

Primary Outcome Measures

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

Observation of chronic toxicity

Secondary Outcome Measures

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

Local control at 2 years

Pattern of recurrence

Full Information

NCT ID

NCT00135161

First Posted

August 24, 2005

Last Updated

December 6, 2022

Sponsor

University Hospital, Ghent

Collaborators

Belgian Federation Against Cancer

1. Study Identification

Unique Protocol Identification Number

NCT00135161

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

September 2003 (Actual)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Ghent

Collaborators

Belgian Federation Against Cancer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Neoplasms

Keywords

neoplasms (squamous cell carcinoma of the head and neck region)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intensity modulated radiation therapy (IMRT).

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

until 3 months after the end of the radiotherapy

Title

Observation of chronic toxicity

Time Frame

until 3 months after the end of the radiotherapy

Secondary Outcome Measure Information:

Title

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

Time Frame

2-4 months after end of radiotherapy

Title

Local control at 2 years

Time Frame

at 2 years

Title

Pattern of recurrence

Time Frame

at 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wilfried De Neve, MD, PhD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Links:

URL

http://www.uzgent.be

Description

Website University Hospital Ghent

Learn more about this trial

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

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