Clinical trial · Interventional
Risk Adapted SABR(SABR) in Stage I NSCLC And Lung Metastases
Risk Adapted Free Flattering Filter Based Stereotactic Ablative Radiotherapy (Sabr) in Stage i Nsclc and Lung Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to evaluate the safety of Stereotactic Ablative Radiotherapy (SBRT) in selected patients with stage I Non Small Cell Lung Cancer (NSCLC) or metastatic lung cancer to demonstrate the feasibility and risks of using an ablative dose-adapted scheme with FFF beams. Other aims are To evaluate the incidence of acute and late complications; To evaluate tumour response to local radiation therapy by means of CT, PET/TC and MRI and To evaluate the impact of local therapy on overall and disease-free survival.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 34 Gy in a single fraction | Radiation | — | UNRESOLVED |
| 54Gy 18Gy/fr. x 3 fractions | Radiation | — | UNRESOLVED |
| 60Gy (12 x 5 fr.s) | Radiation | — | UNRESOLVED |
| 60Gy (7.5Gy x 8fr.) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- A. 34 Gy in a single fraction
- description
- 34 Gy by single fraction Risk-adapted radiation dose.
- interventionNames
- Radiation: 34 Gy in a single fraction
- type
- EXPERIMENTAL
- label
- B. 54Gy (18Gy/fr. x 3 fractions)
- description
- 54Gy administered in 3 fraction of 18 Gy, risk adapted radiation dose
- interventionNames
- Radiation: 54Gy 18Gy/fr. x 3 fractions
- type
- EXPERIMENTAL
- label
- C. 50Gy (12 x 5 fr.s)
- description
- 54Gy administered in 5 fraction of 12 Gy, risk adapted radiation dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-confirmed primary lung cancer or lung metastasis from another primary tumour or positive PET/CT suggestive for primary tumour(SUV MAX\> 4). * Tumour size \< 5 cm in diameter prior to treatment. * Medically inoperable patients as determined by the multidisciplinary thoracic tumour board, or medically operable patients who refuse surgery. * Life expectancy of \>12 months. * Criterion for medical inoperability include: Overall clinical assessment at the UCLA thoracic tumour board. Reduced Pulmonary Function (FEV1, DLCO, etc) based on one major or two minor criterion as described below: Minor Criteria: Age \> 75, FEV1 51- 60% predicted, or FEV1 1-1.2L, DLCO 51%-60% predicted, pulmonary hypertension, poor left ventricular function (EF \< 40% or less), resting or exercise arterial pO2 \< 55 mmHg, and pCO2 \> 45 mmHg. * Age \> 18 years. * KPS \> 70. * Barthel score \>40 * Baseline computed tomography scans of the chest, pulmonary test function, and positron emission tomography no more than 2 months before treatment. * If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented. * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Prior thoracic radiation treatment wich dose contribution can be expected in the new SBRT plan. * More than two lesions per lobe. * Active infections requiring systemic antibiotics. * Age \<18 years old. * KPs \< 70. * Barthel Total Score \< 40.
References
Publications (0)
Data not yet available