About this trial
A registry-based randomized phase II trial. A total of 46 patients with metastatic cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Metastatic cancer (any histology), with pathological or radiological proof of metastasis
Ability to provide written informed consent
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Disqualifiers
Pregnancy or breastfeeding
Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.
Presence of spinal cord compression
Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel
Trial design
Parallel
Treatments tested in this trial
Standard arm
Other interventionPatients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy.
Experimental arm
RadiationSABR to all oligoprogressive lesions + continuation of current systemic therapy
Treatment groups
Trial outcomes
Primary outcomes
Progression free survival
PFS defined from randomization to disease progression at any site or death
Secondary outcomes
Overall survival
OS defined as time from randomization to time of death from any cause.
Quality of life Measured using the FACT-G tool, patient reported outcome- CTCAE (PRO-CTCAE) and Quality of life 5-level EQ-5D
Measured using the FACT-G tool, patient reported outcome- CTCAE (PRO-CTCAE) and quality of life 5-level EQ-5D
Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Measured using the Common Terminology Criteria for Adverse Events
Local control
Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm
Sponsors and contacts
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