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A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Ghent Identifier:
First received: September 23, 2010
Last updated: January 23, 2014
Last verified: January 2014
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 Intervention Phase
Squamous Cell Carcinoma
Other: repetitive per-treatment [18F]FDG-PET for treatment adaptation
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: September 2010
Study Completion Date: March 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
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Please refer to this study by its identifier: 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 Identifier: NCT01208883     History of Changes
Other Study ID Numbers: 2010/510
Study First Received: September 23, 2010
Last Updated: January 23, 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 processed this record on March 28, 2017