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

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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:
Belgian Federation Against Cancer
Information provided by (Responsible Party):
University Hospital, Ghent

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).

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer
Study Start Date : September 2003
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy [ Time Frame: until 3 months after the end of the radiotherapy ]
  2. Observation of chronic toxicity [ Time Frame: until 3 months after the end of the radiotherapy ]

Secondary Outcome Measures :
  1. Therapy response (2-4 months after end of radiotherapy) [ Time Frame: 2-4 months after end of radiotherapy ]
  2. Local control at 2 years [ Time Frame: at 2 years ]
  3. Pattern of recurrence [ Time Frame: at 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00135161     History of Changes
Other Study ID Numbers: 2003/202
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

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 by Site
Neoplasms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action