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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Belgian Federation Against Cancer
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00135161
First received: August 24, 2005
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Head and Neck Neoplasms
 Procedure: FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy [ Time Frame: until 3 months after the end of the radiotherapy ] [ Designated as safety issue: No ]
  • Observation of chronic toxicity [ Time Frame: until 3 months after the end of the radiotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Therapy response (2-4 months after end of radiotherapy) [ Time Frame: 2-4 months after end of radiotherapy ] [ Designated as safety issue: No ]
  • Local control at 2 years [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
  • Pattern of recurrence [ Time Frame: at 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2003
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135161

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Belgian Federation Against Cancer
Investigators
Principal Investigator: Wilfried De Neve, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Website University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00135161     History of Changes
Other Study ID Numbers: 2003/202
Study First Received: August 24, 2005
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
neoplasms (squamous cell carcinoma of the head and neck region)

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 22, 2013