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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01208883
First received: September 23, 2010
Last updated: January 23, 2014
Last verified: January 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01208883     History of Changes
Other Study ID Numbers: 2010/510
Study First Received: September 23, 2010
Last Updated: January 23, 2014
Health Authority: Belgium: Ethics Committee

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
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on April 16, 2014