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

Launched by OSLO UNIVERSITY HOSPITAL · Feb 29, 2024

Keywords

ClinConnect Summary

The RADPAINT-3 trial is studying a new approach to treating head and neck cancer using a technique called "dose painting." This method aims to deliver higher doses of radiation to specific parts of the tumor that are more active, based on imaging done before treatment. The goal is to see if this targeted approach is as safe as the standard radiation treatment, which uses a uniform dose across the entire tumor. Researchers want to find out how often patients experience serious side effects, like severe mouth sores, one year after their treatment. The trial will include about 100 patients and will take place over six years.

To be eligible for the trial, participants must be adults over 18 years old with certain types of head and neck cancers that are not linked to the human papillomavirus (HPV). They should be planned to receive standard curative radiation treatment, possibly combined with chemotherapy. Throughout the study, participants will receive regular check-ups and some will undergo additional blood tests to help researchers understand how well the treatment is working and its effects on the body. This trial is an important step in exploring safer and more effective treatment options for head and neck cancer.

Gender

ALL

Eligibility criteria

• 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