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

Study Overview
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Brief Summary
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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.

Official Title
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A FEASIBILITY STUDY ON CONTINUOUS ADAPTIVE [18F]FDG-PET-GUIDED RADIOTHERAPY FOR HEAD AND NECK CANCER

Conditions
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Squamous Cell Carcinoma

Intervention / Treatment
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* Other: repetitive per-treatment [18F]FDG-PET for treatment adaptation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: repetitive per-treatment [18F]FDG-PET for treatment adaptation<br> | Other: repetitive per-treatment [18F]FDG-PET for treatment adaptation<br>* repetitive per-treatment [18F]FDG-PET for treatment adaptation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary non-operated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.