Comparing dose painting with standard radiotherapy for head and neck cancer
RAdiotherapy With FDG-PET Guided Dose-PAINTing Compared With Standard Radiotherapy for Primary Head and Neck Cancer-3 Randomized, Multicentre, Phase II Trial
This study is testing a new way of giving radiation treatment for head and neck cancer to see if it causes fewer severe mouth sores than the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | cetuximab, chemotherapy |
| Locations | 3 sites (Bergen and 2 other locations) |
| Trial ID | NCT06297902 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically confirmed invasive squamous cell carcinoma of the head and neck region who are planned for curative radiotherapy.
Not a fit: Patients with early-stage cancers, certain HPV-positive oropharyngeal carcinomas, or those with conditions like diabetes or active smoking may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced side effects and improved treatment outcomes for patients with head and neck cancer.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using advanced imaging techniques to tailor radiotherapy doses, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bergen and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.