NCT06918951 Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers
| NCT ID | NCT06918951 |
| Status | Recruiting |
| Phase | — |
| Sponsor | British Columbia Cancer Agency |
| Condition | Oligoprogression |
| Study Type | INTERVENTIONAL |
| Enrollment | 194 participants |
| Start Date | 2025-12-04 |
| Primary Completion | 2030-06-01 |
Trial Parameters
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Brief Summary
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) and control (palliative radiation) arms; * To compare the treatment related toxicity among participants in each arm; * To evaluate and compare the quality of life among participants in each arm; * To assess the cost-effectiveness of the experimental arm compared to the control arm.
Eligibility Criteria
Inclusion Criteria: 1. Age 19 or older 2. Able to provide informed consent 3. Histologically confirmed solid malignancy (excluding lymphoma or myeloma) with metastatic disease detected on imaging 4. Biopsy of metastasis at some time prior to enrollment is preferred, but not required 5. ECOG performance status 0-2 6. Life expectancy ≥ 6 months 7. Progression meeting RECIST criteria in up to 5 individual lesions. Progression may be defined as: 1. Progression of an individual metastasis according to RECIST 1.1 criteria (≥ 20% enlargement of the tumour vs. baseline or nadir, taking as reference the smallest diameter seen prior to starting or during systemic therapy, and associated with a 5 mm minimum increase in size) OR 2. Unambiguous development of a new metastatic lesion at least 5 mm in size OR 3. Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2-3 months apart with a minimum 5 mm increase in size from baseline. 4. A progressing primary tumor is eligible