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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01208883
First Posted: September 24, 2010
Last Update Posted: January 24, 2014
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.
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose
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: None (Open Label)
Primary Purpose: Treatment
Official Title: A FEASIBILITY STUDY ON CONTINUOUS ADAPTIVE [18F]FDG-PET-GUIDED RADIOTHERAPY FOR HEAD AND NECK CANCER

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

  Eligibility

Information from the National Library of Medicine

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

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
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): NCT01208883


Locations
Belgium
University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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 Submitted: September 23, 2010
First Posted: September 24, 2010
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
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action