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Active, Not Recruiting

NCT Number: NCT04910308

RAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, N-0424, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FDG-PET guided dose painting

Radiation

The radiation dose inside the gross tumor volume is increased according to the voxel intensity (SUV - standardized uptake value) of pre-treatment FDG PET.

Primary outcomes

  1. Late toxicity - mucosal ulcer

    Time frame: 1 year

    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.

  2. Acute or late toxicity

    Time frame: 1 year

    Any life-threatening toxicity (CTCAE v5.0) related to radiotherapy. This endpoint will be assessed by clinical examination.

Secondary outcomes

  1. Acute toxicity

    Time frame: < 3 months after radiotherapy

    CTCAE v5.0

  2. Late toxicity

    Time frame: 1 year

    CTCAE v5.0

  3. Loco-regional control

    Time frame: 3 years

    FDG PET/CT at 3 months. Imaging thereafter if clinical progression.

  4. Disease free survival

    Time frame: 3 years

    FDG PET/CT at 3 months. Imaging thereafter if clinical progression.

  5. Overall survival

    Time frame: 3 years

    Date from central registry.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Acronym: RADPAINT-2

Important dates

Study start
2021
Primary completion
2022
Study completion
2025
First posted
Jun 2, 2021
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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