Dose Painting of Head and Neck Cancer (RADPAINT)
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|ClinicalTrials.gov Identifier: NCT03847480|
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Radiation: FDG-PET guided dose painting||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dose Painting of Head and Neck Cancer - The RADPAINT Pilot Study|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2025|
- 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.
- Late toxicity - mucosal ulcer [ Time Frame: 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 [ Time Frame: 1 year ]Any life-threatening toxicity (CTCAE v4.0) related to radiotherapy. This endpoint will be assessed by clinical examination.
- Acute toxicity [ Time Frame: < 3 months after radiotherapy ]CTCAE v4.0
- Late toxicity [ Time Frame: 1 year ]CTCAE v4.0
- Loco-regional control [ Time Frame: 3 years ]FDG PET/CT at 3 months. Imaging thereafter if clinical progression.
- Disease free survival [ Time Frame: 3 years ]FDG PET/CT at 3 months. Imaging thereafter if clinical progression.
- Overall survival [ Time Frame: 3 years ]Date from central registry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847480
|Contact: Einar Dale, MD PhDfirstname.lastname@example.org|
|Contact: Cecilie Amdal, MD PhDemail@example.com|
|Oslo University Hospital||Recruiting|
|Sub-Investigator: Torbjørn Furre, MSc|
|Sub-Investigator: Morten E Evensen, BSc|
|Sub-Investigator: Eirik Malinen, PhD|
|Sub-Investigator: Ayca M Løndalen, MD PhD|
|Sub-Investigator: Lars TG Mikalsen, PhD|
|Study Director:||Stein Kaasa, MD PhD||Oslo University Hospital|