Clinical trial · Interventional
Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients
A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy
- 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)
A multi-centre randomized controlled open-label trial in medically inoperable patients with biopsy-proven early stage non-small cell lung cancer (NSCLC). Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) or conventional radiotherapy (CRT) in a 2:1 ratio. Radiotherapy will be administered as soon as possible following randomization and subjects will be followed for 5 years post-randomization for cancer recurrence, toxicity and survival. The primary outcome is local control (LC). The trial will be conducted at 16-20 clinical centres throughout Canada.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Radiotherapy (CRT) | Radiation | — | UNRESOLVED |
| Stereotactic Body Radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stereotactic Body Radiotherapy
- description
- Stereotactic Body Radiotherapy (SBRT)
- interventionNames
- Radiation: Stereotactic Body Radiotherapy (SBRT)
- type
- ACTIVE_COMPARATOR
- label
- Conventional Radiotherapy
- description
- Conventional Radiotherapy (CRT)
- interventionNames
- Radiation: Conventional Radiotherapy (CRT)
Primary outcomes (1)
- measure
- Local Control
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. T1/T2a N0 M0 NSCLC, either by: (a) histological confirmation (squamous cell, adenocarcinoma, large cell carcinoma, or not specified) and CT thorax and/or PET-CT evidence, or (b) a suspicious growing nodule on serial CT imaging, with malignant PET Fluorodeoxyglucose (FDG) avidity, for which a biopsy would be extremely risky. 2. Deemed medically inoperable (as reviewed by a thoracic surgeon and defined as surgically resectable but, because of underlying physiological medical problems \[e.g. chronic obstructive pulmonary disease (COPD), heart disease\], surgery is contraindicated) or Radiotherapy is preferred by the patient due to high operable risk. Exclusion Criteria: 1. Less than 18 years of age. 2. Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher. 3. Prior invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer). 4. History of ataxia telangiectasia. 5. Previous radiotherapy (RT) in the vicinity of the tumour, such that significant overlap could occur. 6. Previous pneumonectomy with Stage I lung cancer in the remaining lung. 7. Diagnosis of idiopathic pulmonary fibrosis and/or interstitial lung disease. 8. Planned for other anticancer therapy (chemotherapy, biological targeted therapy). 9. Female, who is currently pregnant or lactating. 10. Geographic inaccessibility for follow-up. 11. Unable to provide informed consent.
References
Publications (2)
- DERIVEDWang Y, Donovan EK, Levine MN, Whelan TJ, Swaminath A, Parpia S; LUSTRE Trial Investigators. Stereotactic Versus Conventional Radiotherapy in Medically Inoperable Stage I Non-Small Cell Lung Cancer: A Bayesian Reanalysis of the LUSTRE Randomized Trial. Clin Lung Cancer. 2026 May;27(4):117-122.e4. doi: 10.1016/j.cllc.2026.03.008. Epub 2026 Mar 26. PMID 41997828
- DERIVEDRosenberg SA, Mak R, Kotecha R, Loo BW Jr, Senan S. The Nordic-HILUS Trial: Ultracentral Lung Stereotactic Ablative Radiotherapy and a Narrow Therapeutic Window. J Thorac Oncol. 2021 Oct;16(10):e79-e80. doi: 10.1016/j.jtho.2021.06.030. No abstract available. PMID 34561039