RAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck (RADPAINT-2)
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|ClinicalTrials.gov Identifier: NCT04910308|
Recruitment Status : Recruiting
First Posted : June 2, 2021
Last Update Posted : July 28, 2021
|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, 3 months, 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 :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Pilot study|
|Masking:||None (Open Label)|
|Official Title:||RAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck|
|Actual Study Start Date :||July 1, 2021|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||December 31, 2024|
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.
- 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.
- 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.
- Acute toxicity [ Time Frame: < 3 months after radiotherapy ]CTCAE v5.0
- Late toxicity [ Time Frame: 1 year ]CTCAE v5.0
- 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): NCT04910308
|Contact: Einar Dale, MD PhDemail@example.com|
|Oslo University Hospital||Recruiting|
|Oslo, Norway, N-0424|
|Contact: Einar Dale, MD PhD +4722934000 firstname.lastname@example.org|
|Study Director:||Stein Kaasa, MD PhD||Oslo University Hospital|