Condition: Oligoprogression · Oligometastatic Disease · OligoProgressive Metastatic Disease · Sponsor: British Columbia Cancer Agency
STOP-2 is a phase III multi-institutional double-blind randomized trial. 194 participants will be enrolled in this trial. Participants will be randomized in a 1:1 ratio between the Control Arm vs. the Experimental Arm. Participants, enrolling oncologists, and the statistician will be blinded to trial arm assignment. In the control arm, radiotherapy will consist of 8 Gy in 1 fraction to all sites of oligoprogression, and the experimental arm will consist of SABR treatment to all sites of oligoprogression. Primary Objectives * To assess the impact of SABR, compared to palliative conventional radiotherapy, on Progression-free survival on next line systemic therapy (PFS-NEST), oncologic outcomes, and Quality of Life (QOL) in participants with 1-5 oligoprogressing lesions. * To assess the feasibility of the clinical trial in terms of accrual and success of double-blinding. Secondary Objectives * To evaluate and compare the impact of SABR and palliative radiation therapy on the overall survival (OS), progression free survival (PFS), polymetastatic progression-free survival (PPFS); * To assess and compare the proportion of participants receiving additional radiation therapy and other metastasis-directed interventions during follow-up between both arms; * To compare the impact of SABR and palliative radiation therapy on the time to initiation of the next line of systemic therapy; * To identify and compare the anatomic sites of disease progression between the experimental (SABR)…
This description comes directly from the study's public registry record.
Sarah Baker, MD, PhD, FRCPC · 604-930-4032 · sarah.baker1@bccancer.bc.ca
Narsis Afghari, MSc. · 604-675-4100 · narsis.afghari@bccancer.bc.ca
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| BC Cancer - Surrey | Surrey, British Columbia, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06918951