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A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided 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: NCT01208883
Recruitment Status : Completed
First Posted : September 24, 2010
Last Update Posted : January 24, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
Treatment adaptation to biological and anatomical changes occurring during treatment can increase the chance of cure at minimized radiation-induced toxicity in head and neck cancer patients. This trial investigates the feasibility of using repetitive per-treatment [18F]FDG-PET acquired during treatment in adaptive [18F]FDG-PET-voxel intensity-based intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT) for head and neck cancer.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma Other: repetitive per-treatment [18F]FDG-PET for treatment adaptation Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2010
Primary Completion Date : October 2011
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: repetitive per-treatment [18F]FDG-PET for treatment adaptation Other: repetitive per-treatment [18F]FDG-PET for treatment adaptation
repetitive per-treatment [18F]FDG-PET for treatment adaptation

Outcome Measures

Primary Outcome Measures :
  1. To assess volume changes of the targets and organs at risk as detected by repetitive per-treatment [18F]FDG-PET/CT. [ Time Frame: at time of per-treatment [18F]FDG-PET/CT ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx.
  • Primary unresectable tumor and/or patients refused surgery.
  • Stage T1-4; T3-4 N0 or Tany N1-3 for cancer of the glottis.
  • Multidisciplinary decision of curative radiotherapy or radiochemotherapy.
  • Karnofsky performance status ≥70%.
  • Age ≥ 18 years old.
  • Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion Criteria:

  • Treatment combined with brachytherapy.
  • Prior irradiation to the head and neck region.
  • Distant metastases.
  • Second primary tumors that are not under control
  • Pregnant or lactating women.
  • Creatinine clearance (Cockcroft-Gault) ≤ 60 mL/min before treatment.
  • Allergy to the CT-contrast agents.
  • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
  • Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Contacts and Locations

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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): NCT01208883

University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Principal Investigator: Wilfried De Neve, MD, PhD University Hospital, Ghent
More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01208883     History of Changes
Other Study ID Numbers: 2010/510
First Posted: September 24, 2010    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014

Keywords provided by University Hospital, Ghent:
Primary non-operated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action