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Clinical Trials/NCT06722885
NCT06722885
Withdrawn
Not Applicable

Observational Study of Stereotactic Body Radiotherapy for Lung Lesions With Markerless Tracking (MLT) on the VERO® SBRT System

Universitair Ziekenhuis Brussel1 site in 1 countryJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Universitair Ziekenhuis Brussel
Locations
1
Primary Endpoint
Rate of patients treated with markerless and markerbased technique
Status
Withdrawn
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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 movement of these tumours represents a clinical problem and a technological challenge. 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. Moreover, the placement of such an implanted fiducial marker is contraindicated for about 30% of the patients and may be associated with complications such as pneumothorax and bleeding. Therefore Brainlab® recently released an update of the VERO SBRT system that allows "Markerless Tracking" (MLT). This markerless technique is currently being implemented at the Radiotherapy Department of UZ Brussel for lung lesions. Within the Spearhead Strategic Research Program "Societal Benefit of Markerless Stereotactic Body Radiotherapy: a Statistical Support based on Quantitative Imaging", the investigators aim at evaluating the implementation of this technique focusing on patient outcomes and clinical feasibility. In order to do so they plan an observational study that will document the feasibility and outcome of patients with lung lesions treated with markerless tracking on the VERO SBRT system at the Radiotherapy Department in UZ Brussel.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
April 30, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mark De Ridder

Prof Dr

Universitair Ziekenhuis Brussel

Eligibility Criteria

Inclusion Criteria

  • Primary NSCLC patients, stage T1-2bN0M0 (TNM 8th edition)
  • Oligometastatic patients with ≤ 3 lung metastases; SBRT as a primary treatment or as a consolidative treatment after induction chemotherapy;
  • \>= 18 years
  • Patients will be recruited via the treating radiotherapist

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Rate of patients treated with markerless and markerbased technique

Time Frame: 1 week

Comparing patient characteristics between markerbased and marker less technique

Local tumor control

Time Frame: 1 year

local control at 1 year

Number of patients with acute toxicity

Time Frame: up to 6 months

according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)

Number of patients with late toxicity

Time Frame: up to 5 years

according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)

Disease free survival

Time Frame: up to 5 years

Disease free survival

Overall survival

Time Frame: up to 5 years

Overall survival

Study Sites (1)

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