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| Name | Class |
|---|---|
| Canadian Cancer Society (CCS) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiotherapy | Experimental | Stereotactic Body Radiotherapy (SBRT) |
|
| Conventional Radiotherapy | Active Comparator | Conventional Radiotherapy (CRT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Radiation |
| ||
| Conventional Radiotherapy (CRT) |
| Measure | Description | Time Frame |
|---|---|---|
| Local Control | Local control is the absence of local recurrence during the study period. This is the time from randomization to primary tumour failure or marginal failure. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall Survival is defined as the time from randomization to death from any cause. Alive subjects will be censored on the date of last follow-up. | 5 years |
| Disease-Free Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anand Swaminath | Ontario Clinical Oncology Group (OCOG) | Principal Investigator |
| Tim Whelan | Ontario Clinical Oncology Group (OCOG) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Centre | Calgary | Alberta | Canada | |||
| Cross Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41997828 | Derived | Wang 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. | |
| 34561039 |
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| Radiation |
|
Disease-Free Survival is defined as the time from randomization to the earliest recurrence of disease or to death attributed to lung cancer.
| 5 years |
| Event-Free Survival | Event-Free Survival is defined as the time from randomization to the earliest documented recurrent disease or death from any cause. | 5 years |
| Lung Cancer-Specific Survival | Lung Cancer-Specific Survival is defined as the time from randomization to death attributable to lung cancer | 5 years |
| Radiation Treatment-Related Death | Radiation Treatment-Related Death is defined as death occurring between 1 to 12 months following treatment, and caused directly by radiation toxicity attributed to either catastrophic hemorrhage or to severe radiation pneumonitis leading to death | 1 to 12 months |
| Toxicity | Acute Toxicity will be assessed at 3 months post-randomization and includes fatigue, dyspnea and esophagitis. Late toxicity will be assessed beyond 3 months and up to 5 years and includes radiation pneumonitis, chest wall pain and rib fracture. | 5 years |
| Quality of Life | Impact on quality of life will be assessed with the European Organization for Research in Treatment of Cancer and the Lung Cancer-specific Module 13 questionnaires. | 2 years |
| Cost-Utility | Cost-Utility will be assessed using the European Quality of Life questionnaire in conjunction with the overall survival results | 3 years |
| Edmonton |
| Alberta |
| T6G 1Z2 |
| Canada |
| Cancer Care Manitoba | Winnipeg | Manitoba | Canada |
| Horizon Health Network | Saint John | New Brunswick | Canada |
| Juravinski Hospital and Cancer Centre | Hamilton | Ontario | Canada |
| Cancer Centre of Southeastern Ontario at the Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| London Regional Cancer Program at London Health Sciences Centre | London | Ontario | Canada |
| Niagara Health System-Walker Family Cancer Centre | St. Catharines | Ontario | Canada |
| Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario | Canada |
| Windsor Regional Cancer Centre | Windsor | Ontario | Canada |
| Charles LeMoyne Hospital | Greenfield Park | Quebec | J4V 2H1 | Canada |
| CHUM Hospital Notre Dame | Montreal | Quebec | Canada |
| Hôpital Maisonneuve-Rosemont | Montreal | Quebec | Canada |
| Montreal General Hospital McGill | Montreal | Quebec | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada |
| Rosenberg 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. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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