Abscopal Effect From Low-dose Radiotherapy in Metastatic Cancer Combined With Stereotactic Body R… (NCT05578274) | Clinical Trial Compass
WithdrawnNot Applicable
Abscopal Effect From Low-dose Radiotherapy in Metastatic Cancer Combined With Stereotactic Body Radiotherapy
Stopped: insufficient participant enrollment
0Started 2025-06
Plain-language summary
Stereotactic body radiotherapy (SBRT) has been known to enhance the abscopal effect by up to 40% when delivered with immune checkpoint inhibitors (ICIs). Recently, preclinical and clinical studies demonstrate that metastatic lesions treated with non-cytotoxic low-dose radiotherapy (LDRT) significantly were reduced in the condition where SBRT and ICIs were administered together. Given that ICIs are highly expensive and some tumors are beyond the indications of ICIs, novel approaches are required to boost the abscopal effect in the absence of ICIs. Therefore, the investigators design a multicenter, randomized clinical trial that investigates the efficacy and safety of LDRT combined with SBRT in metastatic cancer patients. The primary endpoint is a lesion-specific response of LDRT lesions (i.e., abscopal effect) evaluated three months after radiotherapy.
Subjects will be randomly allocated into two groups (1:1) with the stratification by planning target volume and previous use of ICIs: control group (SBRT in three fractions) or experimental group (SBRT + LDRT in three factions). Unless patients agree with randomization, subjects will participate in a prospective cohort study.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Randomization study: Patients who can provide their written informed consent
* Cohort study: Patients who do not consent to randomization and who are able to consent to a prospective cohort study and provide written informed consent
* Age ≥19 years
* Patients with histologically confirmed primary solid (irrespective of the status of the primary tumor)
* Patients with ECOG performance status 0-2
* Patients planning stereotactic body radiotherapy for extracranial metastases
* Based on RECIST v1.1, patients with at least one extracranial measurable lesion other than SBRT lesions
* Patients with one or more measurable lesions, which are not suitable for SBRT or palliative radiotherapy and can be considered for LDRT (bone metastasis is not indicated for LDRT)
* Patients with hematologic function suitable for radiotherapy (absolute neutrophil count ≥1,500/mm\^3, hemoglobin ≥9 g/dL, platelet count ≥100,000/mm\^3)
* Patients with a life expectancy of 6 months or more according to the researcher's judgment
Exclusion Criteria:
* Patients participating in other clinical studies that may affect the efficacy/safety of this clinical study
* Patients with brain metastasis
* Patients planning SBRT for all measurable lesions due to oligometastasis
* Patients with a history of radiotherapy for extracranial metastases within 3 months of the enrollment
* Patients unable to cooperate with stereotactic body radiotherapy
* Patients who are pregnant or planning to
* Patients…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Abscopal effect rate of low-dose radiotherapy lesions
Timeframe: 3 months after completion of radiotherapy