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A registry-based randomized screening phase II trial. A total of 68 patients with metastatic non small cell lung cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Active Comparator | Switch to subsequent systemic therapy line, best supportive care or continue current systemic line |
|
| Experimental SABR arm | Experimental | Definitive SABR to oligoprogressive lesions + continue current systemic therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SABR | Radiation | SABR to all oligoprogressive lesions + continuation of current systemic therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS defined from randomization to disease progression at any site or death | 5 years |
| OS | OS defined as time from randomization to time of death from any cause. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE) | Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE) | 5 years |
| Quality of life 5-level EQ-5D (EQ-5D-5L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvine Benth | Contact | 514-890-8254 | silvine.benth.chum@ssss.gouv.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Houda Bahig, MD PhD | Centre hospitalier de l'Université de Montréal (CHUM) | Study Chair |
| Bertrand Routy, MD PhD | Centre hospitalier de l'Université de Montréal (CHUM) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal | Recruiting | Montreal | Quebec | H2X 3E4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42032732 | Derived | Giguere P, Bahig H, Westra S, Roberge D, Bourque JM, Masucci GL, Nkurunziza ES, Freire V, Belliveau C, Duplan D, Vigneault E, Wong P, Lang P, Menard C. Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation. Trials. 2026 Apr 24;27(1):437. doi: 10.1186/s13063-026-09709-0. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Randomized screening phase II trial
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| Standard of care | Other | Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy. |
|
questionnaire |
| 5 years |
| Grade ≥ 3 toxicity | Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | 5 years |
| Local control | Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm | 5 years |
| Time to next systemic therapy | Defined as time from randomization to time of subsequent therapy line | 5 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |