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

Phase 1

Completed

• Conditions: Squamous Cell Carcinoma
• Interventions: Other: repetitive per-treatment [18F]FDG-PET for treatment adaptation

• Registration Number: NCT01208883
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-09-23
• Study First Posted: 2010-09-24
• Primary Completion: 2011-10
• Study Completion: 2012-03
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To assess volume changes of the targets and organs at risk as detected by repetitive per-treatment [18F]FDG-PET/CT.	at time of per-treatment [18F]FDG-PET/CT

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium