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RAdiotherapy With FDG-PET Guided Dose-PAINTing Compared With Standard Radiotherapy for Primary Head and Neck Cancer-3

RecruitingNAAges 18 Years - anyAllOslo University Hospital
NCT06297902 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The objective of the RADPAINT-3 trial is to investigate whether dose painting is safe compared to standard radiotherapy. RADPAINT-3 is a randomized, non-inferiority, multi-center phase II study, initiated at the Section for Head and Neck Cancer, Department of Oncology, Oslo University Hospital, accruing from first half of 2024. The primary endpoint is frequency of grade ≥ 3 (CTCAE v5.0) mucosal ulcers one year after treatment. The expected inclusion period is three years, total study duration is six years and planned inclusion number is 100 patients. The collaborating sites are St Olav´s Hospital and Haukeland University Hospital. The patients will be randomized 1:1 to either standard radiotherapy (2 Gy x 34; total dose 68 Gy) or experimental radiotherapy (dose painting). All patients will have 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission computed tomography (FDG-P

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Histologically or cytologically verified invasive squamous cell carcinoma of the head and neck region; Sinonasal cancer, oral cavity cancer, hypopharynx cancer, larynx cancer, HPV negative oropharyngeal cancer and T4 (any N) HPV positive oropharyngeal cancer. 2. Patients planned for standard curative RT (with or without concomitant chemotherapy \[cisplatin, or cetuximab\], with or without nimorazole hypoxic cell radiosensitizer) 3. Age \> 18 years 4. WHO performance status 0-2 5. Signed informed consent 6. Ability to understand information about the study and to complete questionnaires Exclusion Criteria: 1. All diagnoses, cT1 cN0-N1 cM0 2. Glottic cancer cT1-T2 cN0 cM0 3. HPV positive oropharyngeal carcinoma T1-T3 (any N) 4. Diabetes mellitus 5. Use of anticoagulant medication 6. Active smoking and/or alcohol abuse
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What it tests

  • Dose painting
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Where

3 sites
Haukeland University Hospital
Bergen, Norway
Oslo University Hospital
Oslo, Norway
St. Olavs Hospital
Trondheim, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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