Dose Painting of Head and Neck Cancer

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Radiation: FDG-PET guided dose painting

• Registration Number: NCT03847480
• Lead Sponsor: Oslo University Hospital

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.

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, 6 months, 1 year, 1.5 years and 3 years after radiotherapy (in addition to the routine follow-up).

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Primary Completion: 2020-03-09
• Study Completion: 2022-12-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose painting	FDG-PET guided dose painting	Dose painting

Primary Outcome Measures

Name	Time	Method
Late toxicity - mucosal ulcer	1 year	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.
Acute or late toxicity	1 year	Any life-threatening toxicity (CTCAE v4.0) related to radiotherapy. This endpoint will be assessed by clinical examination.

Secondary Outcome Measures

Name	Time	Method
Loco-regional control	3 years	FDG PET/CT at 3 months. Imaging thereafter if clinical progression.
Acute toxicity	< 3 months after radiotherapy	CTCAE v4.0
Disease free survival	3 years	FDG PET/CT at 3 months. Imaging thereafter if clinical progression.
Overall survival	3 years	Date from central registry.
Late toxicity	1 year	CTCAE v4.0

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway