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

NCT06722885 | Withdrawn DMC

• 1 other identifier: SBRT_LOV
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Stereotactic Body Radiotherapy; Lung Diseases; Lung Cancer Metastatic; Lung Cancer Stage IV; Lung Cancer, Nonsmall Cell

Keywords

radiotherapy; stereotactic body radiotherapy; markerless tracking; clinical feasibility; implementation

Outcome Measures

Primary Outcomes (6)

• 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

• 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

Study Arms (3)

Markerless tracking

* 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

Radiation: Standard radiotherapy treatment

ITV approach

* 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

Radiation: Standard radiotherapy treatment

Markerbased tracking

* 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

Radiation: Standard radiotherapy treatment

Interventions

Standard radiotherapy treatment RADIATION

* 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

ITV approach; Markerbased tracking; Markerless tracking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lung lesions or primary lung cancer

You may qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

MeSH Terms

Conditions

Lung Neoplasms; Lung Diseases; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Mark De Ridder, MD, PhD

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

• Christine Collen, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: December 9, 2024
• Study Start: January 1, 2022
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

BE (1)