RAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck

Study Overview
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Brief Summary
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Dose-painting may increase the chance of cure at minimised radiation-induced toxicity in volumetric-arc radiotherapy (VMAT) for head and neck cancer. This trial (RADPAINT) investigates the safety of FDG-PET guided radiotherapy using VMAT dose-painting by contours for patients with head and neck cancer of poor prognosis.

Detailed Description
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In this study, radiotherapy is planned using 18F-FDG PET/CT (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography) making one experimental dose-painting by contours SIB (simultaneous integrated boost) plan with a maximum point dose of 83 Gy. The participants will be given 73 Gy and 78 Gy minimum doses to two GTVs (gross tumor volumes inside the conventional GTV (68 Gy). GTV_73Gy and GTV_78Gy are determined from the SUV (standardized uptake values) from the 18F-FDG PET/CT according to the formula proposed by the Ghent group (Van der Straeten et al, R&O -06). It is expected to keep the level of normal tissue side-effects within or slightly above the level of conventional radiotherapy (i.e. maximum dose of 68 Gy). In addition to the routine follow-up, the participants will be examined with 18F-FDG PET/CT (3 months after treatment and toxicity scoring at 6 weeks, 3 months, 6 months, 1 year, 1.5 years and 3 years after radiotherapy (in addition to the routine follow-up).

Official Title
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RAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Radiation: FDG-PET guided dose painting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically verified invasive squamous cell carcinoma of the head and neck region; Sinonasal, oral cavity, hypopharynx cancer, larynx cancer, HPV-unrelated (p16 negative and/or HPV DNA negative) oropharyngeal cancer and TNM (primary tumor, regional nodes, metastasis) stage T4 any N M0 HPV-related (p16 positive and/or HPV DNA positive) oropharyngeal cancer. Patients planned for standard curative treatment (radical radiotherapy with or without concomitant chemotherapy, with or without nimorazole hypoxic cell radiosensitizer) Planned treatment at the Oslo University Hospital Age > 18 years WHO (World Health Organization) performance status 0-2 Exclusion Criteria: TNM (primary tumor, regional nodes, metastasis) stage cT1 cN0-N1 cM0 Glottic cancer cT1-T2 cN0 cM0 HPV-related oropharyngeal carcinoma cT1-T3 (any N) Cancer in the soft palate Diabetes mellitus Use of anticoagulant (or platelet inhibitor) Active smoking and/or alcohol abuse

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
Interventional Model Description: Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose painting<br>Dose painting | Radiation: FDG-PET guided dose painting<br>* The radiation dose inside the gross tumor volume is increased according to the voxel intensity (SUV - standardized uptake value) of pre-treatment FDG PET.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late toxicity - mucosal ulcer | The study will be stopped if ≥ 3 patients experience late toxicity as assessed by CTCAE v5.0; mucosal ulcers grade ≥ 3 without healing within the first year after radiotherapy. This endpoint will be assessed by clinical examination. | 1 year | 
| Acute or late toxicity | Any life-threatening toxicity (CTCAE v5.0) related to radiotherapy. This endpoint will be assessed by clinical examination. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity | CTCAE v5.0 | < 3 months after radiotherapy | 
| Late toxicity | CTCAE v5.0 | 1 year | 
| Loco-regional control | FDG PET/CT at 3 months. Imaging thereafter if clinical progression. | 3 years | 
| Disease free survival | FDG PET/CT at 3 months. Imaging thereafter if clinical progression. | 3 years | 
| Overall survival | Date from central registry. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dose painting, 18F-FDG, Positron emission tomography, Radiotherapy