Lung Cancer, Lung Cancer Metastatic, Lung Cancer, Nonsmall Cell, Lung Cancer Stage IV, Lung Diseases, Stereotactic Body Radiotherapy
Conditions
Keywords
radiotherapy, stereotactic body radiotherapy, markerless tracking, clinical feasibility, implementation
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.
Interventions
RADIATIONStandard radiotherapy treatment
* 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
Sponsors
Universitair Ziekenhuis Brussel
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Primary NSCLC patients, stage T1-2bN0M0 (TNM 8th edition) 2. Oligometastatic patients with ≤ 3 lung metastases; SBRT as a primary treatment or as a consolidative treatment after induction chemotherapy; 3. \>= 18 years 4. Patients will be recruited via the treating radiotherapist \-
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients treated with markerless and markerbased technique | 1 week | Comparing patient characteristics between markerbased and marker less technique |
| Local tumor control | 1 year | local control at 1 year |
| Number of patients with acute toxicity | up to 6 months | according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) |
| Number of patients with late toxicity | up to 5 years | according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) |
| Disease free survival | up to 5 years | Disease free survival |
| Overall survival | up to 5 years | Overall survival |
Countries
Belgium
Outcome results
None listed