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SUNSET: SBRT for Ultra-central NSCLC- a Safety and Efficacy Trial

StatusActive, Not Recruiting
PhasePhase 1
Started2018-01-19
View on ClinicalTrials.gov ↗

Amendment history

2025-09-12
minor
Study Status v13
Completion date2024-10→2026-09
2024-02-28
minor
Study Status v12
Completion date2023-10→2024-10
2023-08-16
minor
Study Status v11
Re-verified, no change to tracked fields
2023-03-16
minor
Study Status v10
Completion date2022-10→2023-10
2022-04-12
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2022-10→confirmed 2021-04-19
Study sitesdetails revised at 7 of 7 sites
Show 8 earlier versions
2021-02-17
minor
Study Status, Contacts/Locations v8
Study sites6→7
2019-07-31
minor
Study Status, Sponsor/Collaborators, Contacts/Locations v7
Study sites5→6
2019-06-18
minor
Study Status, Contacts/Locations v6
Study sites4→5
2019-03-10
minor
Study Status, Arms and Interventions, Contacts/Locations v5
Study sites3→4
2018-11-29
minor
Study Status, Contacts/Locations v4
Study sites2→3
2018-10-22
minor
Study Status, IPDSharing v3
Re-verified, no change to tracked fields
2018-07-23
minor
Study Status, Contacts/Locations v2
Study sites1→2
2018-01-23
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2017-10→confirmed 2018-01-19
Study sites0→1
2017-10-05
minor
Original filing
This multi-centre phase I dose-escalation study will use a time-to-event continual reassessment method (TIT-CRM). Accrual will start at level 1 (60 Gy in 8 fractions). Patients will be assigned to treatment doses using the TITE-CRM model. The model will use all available information from previously accrued patients to assign the highest dose with a predicted risk of grade 3 toxicity of 30% or less.
Trial Details
NCT Number NCT03306680
Lead Sponsor London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions Non Small Cell Lung Cancer
Enrollment 30 participants
Start Date 2018-01-19
Primary Completion 2021-04-19 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2025-09-18