Dose Painting of Head and Neck Cancer
RADPAINT
1 other identifier
interventional
7
1 country
1
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 FDG-PET guided radiotherapy using VMAT dose-painting by contours for patients with head and neck cancer of poor prognosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable head-and-neck-cancer
Started Dec 2018
Typical duration for not_applicable head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 14, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2022
CompletedFebruary 21, 2025
February 1, 2025
1.3 years
February 14, 2019
February 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Late toxicity - mucosal ulcer
The study will be stopped if ≥ 2 patients experience mucosal ulcers grade ≥ 3 (CTCAE v 3.0/v4.0) without healing within the first year after radiotherapy. This endpoint will be assessed by clinical examination.
1 year
Acute or late toxicity
Any life-threatening toxicity (CTCAE v4.0) related to radiotherapy. This endpoint will be assessed by clinical examination.
1 year
Secondary Outcomes (5)
Acute toxicity
< 3 months after radiotherapy
Late toxicity
1 year
Loco-regional control
3 years
Disease free survival
3 years
Overall survival
3 years
Study Arms (1)
Dose painting
EXPERIMENTALDose painting
Interventions
The radiation dose inside the gross tumor volume is increased according to the voxel intensity (SUV - standardized uptake value) of pre-treatment FDG PET.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically verified invasive squamous cell carcinoma of the head and neck region; Oral cavity, hypopharynx cancer, larynx cancer and HPV ((human papillomavirus) negative oropharyngeal cancer.
- Patients planned for standard curative treatment (radical radiotherapy with or without concomitant chemotherapy, with nimorazole hypoxic cell radiosensitizer)
- Planned treatment at the Oslo University Hospital
- Age \> 18 years
- WHO (World Health Organization) performance status 0-2
You may not qualify if:
- TNM (primary tumor, regional nodes, metastasis) stage cT1 cN0-N1 cM0
- Glottic cancer cT1-T2 cN0 cM0
- HPV positive oropharyngeal carcinoma
- Cancer in the soft palate
- Diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital
Oslo, Norway
Related Publications (1)
Evensen 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: 34991431RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stein Kaasa, MD PhD
Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Consultant
Study Record Dates
First Submitted
February 14, 2019
First Posted
February 20, 2019
Study Start
December 1, 2018
Primary Completion
March 9, 2020
Study Completion
December 16, 2022
Last Updated
February 21, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share