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Completed

NCT Number: NCT01208883

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

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.

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Key information

Conditions

Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Laryngeal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Otorhinolaryngologic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Ghent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

repetitive per-treatment [18F]FDG-PET for treatment adaptation

Other

repetitive per-treatment [18F]FDG-PET for treatment adaptation

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 24, 2010
Registry last updated
Jan 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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