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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 22, 2014