Status:
ACTIVE_NOT_RECRUITING
RAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck
Lead Sponsor:
Oslo University Hospital
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 F...
Detailed Description
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 (si...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04910308
Start Date
July 1 2021
End Date
August 1 2025
Last Update
December 17 2024
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, N-0424