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

August 24, 2005
February 1, 2013
September 2003
August 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy.
  • Observation of chronic toxicity.
Complete list of historical versions of study NCT00135161 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Therapy response (2-4 months after end of radiotherapy)
  • Local control at 2 years
  • Pattern of recurrence
Not Provided
Not Provided
 
Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer
Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer

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

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Neoplasms
Procedure: FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).
FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).
Experimental: Intensity modulated radiation therapy (IMRT).
Intervention: Procedure: FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00135161
2003/202
No
University Hospital, Ghent
University Hospital, Ghent
Belgian Federation Against Cancer
Principal Investigator: Wilfried De Neve, MD, PhD University Hospital, Ghent
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP