Clinical trial · Interventional
RAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck
NCT04910308CI-TRIAL-00083826RADPAINT-2active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 FDG-PET guided radiotherapy using VMAT dose-painting by contours for patients with head and neck cancer of poor prognosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDG-PET guided dose painting | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose painting
- description
- Dose painting
- interventionNames
- Radiation: FDG-PET guided dose painting
Primary outcomes (2)
- measure
- Late toxicity - mucosal ulcer
- timeFrame
- 1 year
- description
- The study will be stopped if ≥ 3 patients experience late toxicity as assessed by CTCAE v5.0; mucosal ulcers grade ≥ 3 without healing within the first year after radiotherapy. This endpoint will be assessed by clinical examination.
- measure
- Acute or late toxicity
- timeFrame
- 1 year
- description
- Any life-threatening toxicity (CTCAE v5.0) related to radiotherapy. This endpoint will be assessed by clinical examination.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 Criteria: 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
References
Publications (1)
- BACKGROUNDEvensen ME, Furre T, Malinen E, Londalen AM, Dale E. Mucosa-sparing dose painting of head and neck cancer. Acta Oncol. 2022 Feb;61(2):141-145. doi: 10.1080/0284186X.2021.2022200. Epub 2022 Jan 6. No abstract available. PMID 34991431