Actively Recruiting
Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers
Led by British Columbia Cancer Agency · Updated on 2025-12-15
194
Participants Needed
1
Research Sites
390 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Able to provide informed consent
- Histologically confirmed solid malignancy (excluding lymphoma or myeloma) with metastatic disease detected on imaging
- Biopsy of metastasis at some time prior to enrollment is preferred but not required
- ECOG performance status of 0 to 2
- Life expectancy of at least 6 months
- Progression in up to 5 individual lesions meeting RECIST criteria or new metastatic lesions at least 5 mm in size
- If on systemic therapy at oligoprogression, must have received therapy for at least 3 months with partial response, complete response, or stable disease prior to progression
- If not on systemic therapy, must have partial response, complete response, or stable disease persisting for at least 3 months prior to progression
- Participants not on systemic therapy must have other disease sites stable or resolved and not planned to receive SABR
- All sites of oligoprogression can be safely treated
- Restaging completed within 12 weeks prior to randomization
- Negative urine pregnancy test within 4 weeks of radiotherapy start for people of child-bearing potential
You will not qualify if you...
- Serious medical conditions preventing radiotherapy, such as ataxia-telangiectasia, scleroderma, Crohn's disease, or ulcerative colitis if GI tract will be treated
- Interstitial lung disease for participants with lung or thoracic lesions
- Significant overlap with previously treated radiation areas beyond allowed dose constraints
- Current malignant pleural effusion, malignant ascites, or leptomeningeal disease
- Inability to treat all sites of oligoprogression
- Need for liver fiducial markers for SABR unless pre-existing markers are present or institution does not require markers
- Brain metastasis larger than 3.5 cm or total brain metastases volume over 30 cc
- Clinical or radiologic spinal cord compression unless surgically treated
- Spinal instability score above 12
- Dominant brain metastasis requiring surgery
- Moderate to severe liver dysfunction (Child Pugh B or C) for participants with liver metastases
- Liver metastases in the "Biliary no fly zone"
- Surgical removal of all progressing metastases leaving no lesions for SABR
- Pregnancy or lactation
AI-Screening
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Trial Site Locations
Total: 1 location
1
BC Cancer - Surrey
Surrey, British Columbia, Canada, V3V 1Z2
Actively Recruiting
Research Team
S
Sarah Baker, MD, PhD, FRCPC
CONTACT
N
Narsis Afghari, MSc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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