RAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck (RADPAINT-2)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Radiation: FDG-PET guided dose painting

Detailed Description

In this study, radiotherapy is planned using 18F-FDG PET/CT (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography) making one experimental "dose-painting by contours" SIB (simultaneous integrated boost) plan with a maximum point dose of 83 Gy. The participants will be given 73 Gy and 78 Gy minimum doses to two GTVs (gross tumor volumes inside the conventional GTV (68 Gy). GTV_73Gy and GTV_78Gy are determined from the SUV (standardized uptake values) from the 18F-FDG PET/CT according to the formula proposed by the Ghent group (Van der Straeten et al, R&O -06). It is expected to keep the level of normal tissue side-effects within or slightly above the level of conventional radiotherapy (i.e. maximum dose of 68 Gy).

In addition to the routine follow-up, the participants will be examined with 18F-FDG PET/CT (3 months after treatment and toxicity scoring at 6 weeks, 3 months, 6 months, 1 year, 1.5 years and 3 years after radiotherapy (in addition to the routine follow-up).

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, N-0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose painting	Radiation: FDG-PET guided dose painting; The radiation dose inside the gross tumor volume is increased according to the voxel intensity (SUV - standardized uptake value) of pre-treatment FDG PET.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late toxicity - mucosal ulcer	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.	1 year
Acute or late toxicity	Any life-threatening toxicity (CTCAE v5.0) related to radiotherapy. This endpoint will be assessed by clinical examination.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute toxicity	CTCAE v5.0	< 3 months after radiotherapy
Late toxicity	CTCAE v5.0	1 year
Loco-regional control	FDG PET/CT at 3 months. Imaging thereafter if clinical progression.	3 years
Disease free survival	FDG PET/CT at 3 months. Imaging thereafter if clinical progression.	3 years
Overall survival	Date from central registry.	3 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Director: Stein Kaasa, MD PhD, Oslo University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): May 27, 2022
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy; Positron emission tomography; Dose painting; 18F-FDG
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 252575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No