NeoplasmsNCT05578274
Abscopal Effect From Low-dose Radiotherapy in Metastatic Cancer Combined With Stereotactic Body Radiotherapy
A study testing SBRT + LDRT and SBRT alone in people with Neoplasms and Secondary Malignant Neoplasm, run by Soonchunhyang University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Neoplasms, Secondary Malignant Neoplasm
- What is being tested?
- SBRT + LDRT and SBRT alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Patients with advanced or multiple malignancies requiring aggressive treatment (excluding skin cancers other than melanoma or intraepithelial cancer)
- Patients who have received systemic steroid therapy or immunosuppressive therapy within 2 weeks of enrollment - Patients with an (e.g. allergic disease, radiation pneumonitis, etc.) active autoimmune disease requiring systemic treatment within the past 2 years, evidence of clinically severe autoimmune disease, or syndrome requiring systemic steroid or immunosuppressive therapy (Patients who need intermittent use of bronchodilators, inhaled steroids, or topical steroid injections, hypothyroid patients on stable hormone replacement therapy, type 1 diabetes patients, or patients recovering from childhood asthma/atopic dermatitis are permitted)
- Patients with active infection requiring systemic treatment
About this study
Official title: Abscopal Effect From the Addition of Low-dose Radiotherapy in Metastatic Cancer Patients Receiving Stereotactic Body Radiotherapy: a Multicenter, Randomized Clinical Study
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.
- Conditions
- Neoplasms, Secondary Malignant Neoplasm
- Being tested
- SBRT + LDRT, SBRT alone
- Keywords
- Neoplasm Metastasis
- Medical subject headings
- Neoplasms, Neoplasms, Second Primary, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT + LDRTRadiation
SBRT is performed according to the protocol of each institution. However, the total fraction of SBRT is fixed to 3, and the treatment interval is maintained for 1-2 days.
The scattered dose should not exceed EQD2 (α/β=10) 2 Gy for non-irradiated lesions.
LDRT is planned to irradiate EQD2 (α/β=10) 6 Gy to lesions, considering the scattered dose caused by SBRT.
If there are non-irradiated lesions, they are defined as internal control, and the total dose is limited to 0.5 Gy or less.
CTV allows up to 5 mm margin for GTV, and 3-10mm for PTV margin from CTV. It is planned that the iso-dose line corresponding to the prescribed dose contains at least 90% of PTV and 95% of GTV.
SBRT aloneRadiation
SBRT is performed according to the protocol of each institution. However, the total fraction of SBRT is fixed to 3, and the treatment interval is maintained for 1-2 days.
The scattered dose should not exceed EQD2 (α/β=10) 2 Gy for non-irradiated lesions.
| Study group | Role | What they receive |
|---|---|---|
| SBRT+LDRT | Experimental | In the experimental group, stereotactic body radiotherapy (SBRT) and low-dose radiotherapy (LDRT) are administered concurrently. SBRT is administered three times, at intervals of 1-2 days, with LDRT. LDRT is planned to irradiate EQD2 6 Gy considering the scattered dose caused by SBRT. Receives: Radiation: SBRT + LDRT |
| SBRT alone | Active comparator | In the control group, stereotactic body radiotherapy (SBRT) alone is performed. SBRT is administered three times, at intervals of 1-2 days. The scattered dose should not exceed EQD2 2Gy to the non-irradiated lesion. Receives: Radiation: SBRT alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abscopal effect rate of low-dose radiotherapy lesions
Measured: 3 months after completion of radiotherapy
Secondary outcomes (2)
Abscopal effect rate of low-dose radiotherapy lesions
Measured: 1, 6, and 12 months after completion of radiotherapy
Overall response rate
Measured: 1, 3, 6, and 12 months after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study startJun 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completion20 Jun 2026
Why it stopped: insufficient participant enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Ah Ram Chang, Soonchunhyang University Hospital
- Investigators
- Ah Ram Chang, MD, PhD, Study chair, Soonchunhayng Universtiy Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578274
- Sponsor's protocol ID
- SCHUH 2022-07-004-001
- Status last verified
- Dec 2024
- First submitted
- 27 Sep 2022
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abscopal Effect From the Addition of Low-dose Radiotherapy in Metastatic Cancer Patients Receiving Stereotactic Body Radiotherapy: a Multicenter, Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05578274
- Acronym / sponsor ID
- SCHUH 2022-07-004-001
- Conditions
- Neoplasms, Secondary Malignant Neoplasm
- Keywords
- Neoplasm Metastasis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: insufficient participant enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRT+LDRT | Experimental | Radiation: SBRT + LDRTIn the experimental group, stereotactic body radiotherapy (SBRT) and low-dose radiotherapy (LDRT) are administered concurrently. SBRT is administered three times, at intervals of 1-2 days, with LDRT. LDRT is planned to irradiate EQD2 6 Gy considering the scattered dose caused by SBRT. |
| SBRT alone | Active comparator | Radiation: SBRT aloneIn the control group, stereotactic body radiotherapy (SBRT) alone is performed. SBRT is administered three times, at intervals of 1-2 days. The scattered dose should not exceed EQD2 2Gy to the non-irradiated lesion. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT + LDRTSBRT is performed according to the protocol of each institution. However, the total fraction of SBRT is fixed to 3, and the treatment interval is maintained for 1-2 days. The scattered dose should not exceed EQD2 (α/β=10) 2 Gy for non-irradiated lesions. LDRT is planned to irradiate EQD2 (α/β=10) 6 Gy to lesions, considering the scattered dose caused by SBRT. If there are non-irradiated lesions, they are defined as internal control, and the total dose is limited to 0.5 Gy or less. CTV allows up to 5 mm margin for GTV, and 3-10mm for PTV margin from CTV. It is planned that the iso-dose line corresponding to the prescribed dose contains at least 90% of PTV and 95% of GTV. | Radiation | SBRT+LDRT |
| SBRT aloneSBRT is performed according to the protocol of each institution. However, the total fraction of SBRT is fixed to 3, and the treatment interval is maintained for 1-2 days. The scattered dose should not exceed EQD2 (α/β=10) 2 Gy for non-irradiated lesions. | Radiation | SBRT alone |
Primary outcome
Abscopal effect rate of low-dose radiotherapy lesions
Time frame: 3 months after completion of radiotherapy
2 secondary outcomes
Abscopal effect rate of low-dose radiotherapy lesions
Time frame: 1, 6, and 12 months after completion of radiotherapy
Overall response rate
Time frame: 1, 3, 6, and 12 months after completion of radiotherapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ah Ram Chang, MD, PhD study chair
Soonchunhayng Universtiy Seoul Hospital
Questions about this trial
What is this clinical trial studying?
A study testing SBRT + LDRT and SBRT alone in people with Neoplasms and Secondary Malignant Neoplasm, run by Soonchunhyang University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abscopal effect rate of low-dose radiotherapy lesions (time frame: 3 months after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.