The VERO® SBRT System radiation machine had water damage and could not be repaired.
SBRT_LOV
Observational Study of Stereotactic Body Radiotherapy for Lung Lesions With Markerless Tracking (MLT) on the VERO® SBRT System
Sponsor study identifier
observational
0
1 country
1
Study Start
January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Stereotactic Body Radiotherapy (SBRT) delivers an ablative dose of radiation to tumours, with high precision. This technique offers an alternative to surgery for lung lesions. The UZ Brussel of the VUB developed with the support of the Hercules foundation (grant for heavy research infrastructure) in collaboration with Brainlab AG a breathing-synchronized radiation technique on the VERO SBRT system, where the radiation beam follows the moving target (dynamic tumour tracking). The implantation of a marker in the tumour is thereby mandatory for its visualization but excluding patients with poor pulmonary function. Therefore Brainlab® recently released an update of the VERO SBRT system that allows "Markerless Tracking". This markerless technique is currently being implemented at the Radiotherapy Department of UZ Brussel for lung lesions. Hence we plan an observational study that will document the outcome of and feasibility for patients with lung lesions treated with markerless tracking on the VERO SBRT system at the Radiotherapy Department in UZ Brussel.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 14, 2019
Actual (reported)January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 9, 2024
Actual (reported)Rate of patients treated with markerless and markerbased technique
Comparing patient characteristics between markerbased and marker less technique
1 week
Local tumor control
local control at 1 year
1 year
Number of patients with acute toxicity
according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)
up to 6 months
* Gross tumor volume for MLT (GTV\_MLT): lesion delineated on stable exhale phase of the 4DCT. * Planning target volume for MLT (PTV\_MLT): GTV + 8 mm isotropic expansion
* Gross tumor volume (GTV): lesion delineated on the ten phases of the 4DCT. * Internal target volume (ITV): propagate all GTV on stable exhale phase of the 4DCT. * Planning target volume for ITV (PTV\_ITV): ITV + 5 mm isotropic expansion
* Gross tumor volume for tracking (GTV\_Track): lesion delineated on stable exhale phase of the 4DCT. * Planning target volume for tracking (PTV\_Track): GTV + 5 mm isotropic expansion
* 3 x 17 Gy for peripheral NSCLC * 4 x 12 Gy in centrally located NSCLC or at \< 1cm from the thoracic wall * 8 x 7,5 Gy if with the predefined dose for NSCLC, the constraints of the organs at risk cannot be met * 5 x 8,5 Gy in case of oligometastases
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with lung lesions or primary lung cancer
Universitair Ziekenhuis Brussel
Brussels, Belgium
Mark De Ridder, MD, PhD
Universitair Ziekenhuis Brussel
Christine Collen, MD
Universitair Ziekenhuis Brussel
0 participants (actual enrollment reported by the registry).
First Submitted
May 14, 2019
First Posted
December 9, 2024
Study Start
January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of patients with late toxicity
according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)
up to 5 years
Disease free survival
Disease free survival
up to 5 years
Overall survival
Overall survival
up to 5 years
Contact the study team to confirm eligibility.
Primary Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 9, 2024
Record last verified: 2024-12
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Source: ClinicalTrials.gov.
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