Actively Recruiting
Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers: A Double-Blind Randomized Phase III Trial
Led by British Columbia Cancer Agency · Updated on 2025-12-15
194
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for adults with oligoprogressive metastatic cancers, which means cancer that has spread but is limited to a few progressing sites. This phase III trial compares stereotactic ablative radiotherapy (SABR) with palliative conventional radiotherapy to see how they affect progression-free survival on the next systemic therapy, cancer outcomes, and quality of life. The study also aims to test the feasibility of enrolling participants and maintaining the study's double-blind design. Participants will be randomly assigned to one of two groups. The control group will receive a single dose of 8 Gy palliative radiotherapy to all progressing cancer sites. The experimental group will receive SABR, which delivers a high dose of precise radiotherapy to the targeted sites. Both groups may continue their current systemic cancer treatments or remain off systemic therapy depending on their situation. The treatments are given to manage up to five progressing lesions. During the study, participants will be monitored regularly for up to five years with scans and assessments at multiple time points. Researchers will evaluate progression-free survival, overall survival, treatment side effects, quality of life using questionnaires, and cost-effectiveness. The trial also tracks when participants start their next systemic therapy and where disease progresses. Safety and quality of life are carefully assessed throughout the study period.
CONDITIONS
Brief 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 before enrollment preferred but not required
- ECOG performance status between 0 and 2
- Life expectancy of at least 6 months
- Progression in up to 5 individual lesions according to RECIST criteria or new metastatic lesions at least 5 mm in size
- If on systemic therapy, must have received at least 3 months of therapy with partial response, complete response, or stable disease before progression
- If not on systemic therapy, must have stable or resolved other disease sites without planned SABR
- All sites of oligoprogression must be safely treatable
- Restaging completed within 12 weeks before 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, including ataxia-telangiectasia, scleroderma, Crohn's disease affecting GI tract, or ulcerative colitis where bowel will be irradiated
- Significant overlap with previous radiation areas exceeding dose limits
- Current malignant pleural effusion, ascites, or leptomeningeal disease
- Inability to treat all sites of oligoprogression
- Liver metastases requiring fiducial markers for SABR that prevent blinding, unless alternative markers available
- Brain metastasis larger than 3.5 cm or total brain metastases volume over 30 cc
- Evidence of spinal cord compression unless surgically treated
- Spinal instability score greater than 12
- Dominant brain metastasis needing surgery
- Moderate to severe liver dysfunction in participants with liver metastases
- Liver metastases in specific biliary zones defined in the trial
- Complete surgical removal of all oligoprogressive metastases
- Pregnant or breastfeeding individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session with follow-up assessments up to 60 months
Participants receive either stereotactic ablative radiotherapy (SABR) or palliative radiotherapy targeting their oligoprogressive metastatic lesions while continuing their current systemic therapy or off systemic therapy as applicable.
1 radiotherapy session plus multiple follow-up visits over 5 years
Duration - Up to 60 months after treatment
Participants are monitored over time for progression-free survival, overall survival, treatment-related toxicities, quality of life, tumor response, and cost-effectiveness outcomes.
Regular follow-up visits at 3, 6, 12, 15, 18, 21, 24, 36, 42, 48, 54, and 60 months
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
N
Narsis Afghari, MSc.
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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