Comparing dose painting with standard radiotherapy for head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The RADPAINT-3 trial aims to evaluate the safety of dose painting in comparison to standard radiotherapy for patients with primary head and neck cancer. This randomized, non-inferiority study will enroll 100 patients across multiple centers, including Oslo University Hospital and its collaborating sites. Participants will undergo FDG-PET imaging prior to treatment and will be randomly assigned to receive either standard radiotherapy or the experimental dose painting approach. The primary outcome measure is the incidence of severe mucosal ulcers one year post-treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Haukeland University Hospital
  Bergen, Norway Recruiting
• Oslo University Hospital
  Oslo, Norway Recruiting
• St. Olavs Hospital
  Trondheim, Norway Not yet recruiting

Study contacts

• Principal investigator: Einar Dale — Oslo University Hospital
• Study coordinator: Einar Dale, PhD
• Email: eindal@ous-hf.no
• Phone: +4722934000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.