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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00135161
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Active, not recruiting
First Posted : August 25, 2005
Last Update Posted : December 5, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

August 24, 2005
August 25, 2005
December 5, 2014
September 2003
August 2015   (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 ]
  • Observation of chronic toxicity [ Time Frame: until 3 months after the end of the radiotherapy ]
  • 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 ]
  • Local control at 2 years [ Time Frame: at 2 years ]
  • Pattern of recurrence [ Time Frame: at 2 years ]
  • 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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Unknown status
40
August 2015
August 2015   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00135161
2003/202
No
Not Provided
Not Provided
University Hospital, Ghent
University Hospital, Ghent
Belgian Federation Against Cancer
Principal Investigator: Wilfried De Neve, MD, PhD University Hospital, Ghent
University Hospital, Ghent
December 2014

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