NeoplasmsKROG22-11NCT05733156
Abscopal Effect from the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy
A study testing SBRT + LDRT in people with Neoplasms and Secondary Malignant Neoplasm, run by Soonchunhyang University Hospital at 2 sites in South Korea.
Trial summary
Recently, MD Anderson Cancer Center reported the phase II trial to investigate high-dose radiotherapy (HDRT, 20-70 Gy) and low-dose radiotherapy (LDRT, 1-10 Gy) for metastatic cancer patients who had undergone immunotherapy. 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 3 Jan 2023to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients who can provide their 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 (three fractions) for extracranial metastases
- Based on RECIST v1.1, patients with at least one extracranial measurable lesion other than SBRT lesions
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- 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.) (The use of steroids for preventive purposes is allowed (e.g., to prevent vomiting during chemotherapy)) 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul
Byoung Hyuck Kim, MD, PhD, +82-2-870-1683, karlly71@hanmail.net
- Not yet recruiting
Soonchunhyang University Seoul Hospital
Seoul
Jae Sik Kim, MD, +82-2-709-3254, myicarusky@gmail.com
About this study
Official title: Abscopal Effect from the Addition of Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy: a Multicenter, Single-arm Clinical Study (KROG 22-11)
Recently, MD Anderson Cancer Center reported the phase II trial to investigate high-dose radiotherapy (HDRT, 20-70 Gy) and low-dose radiotherapy (LDRT, 1-10 Gy) for metastatic cancer patients who had undergone immunotherapy. HDRT or HDRT+LDRT was conducted in two respective groups and the treatment group was determined according to the disease status of participants, not randomization. Immunotherapy was maintained in this clinical study. Therefore, we aim to investigate this abscopal effect from adding LDRT to HDRT, irrespective of previous immunotherapy, in this multicenter, single-arm study.
- Conditions
- Neoplasms, Secondary Malignant Neoplasm
- Being tested
- SBRT + LDRT
- 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
Stereotactic body radiotherapy (SBRT) and low-dose radiotherapy (LDRT) are administered concurrently. SBRT is administered three times, at intervals of 1-2 days, and patients are treated with LDRT along with SBRT. LDRT is planned to irradiate EQD2 6 Gy considering the scattered dose caused by SBRT.
| Study group | Role | What they receive |
|---|---|---|
| SBRT + LDRT | Experimental | Not described Receives: Radiation: SBRT + LDRT |
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
The proportion of patients with an abscopal response of low-dose radiotherapy lesions assessed by RECIST v1.1
Measured: 3 months after completion of radiotherapy
Secondary outcomes (6)
Abscopal effect rate of low-dose radiotherapy lesions
The proportion of patients with an abscopal response of low-dose radiotherapy lesions assessed by RECIST v1.1
Measured: 1, 6, and 12 months after completion of radiotherapy
Overall response rate
The proportion of patients showing complete or partial response of metastatic lesions
Measured: 1, 3, 6, and 12 months after completion of radiotherapy
Progression-free survival rate
From the date of enrollment to the date of progression or death assessed by RECIST v1.1
Measured: 12 months after completion of radiotherapy
Overall survival rate
From the date of enrollment to the date of death or last follow-up assessed by RECIST v1.1
Measured: 12 months after completion of radiotherapy
Adverse event
The proportion of patients with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 12 months after completion of radiotherapy
Immune cell subsets of peripheral blood and tissue samples
Number of immune cell count
Measured: 1 and 3 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 posted17 Feb 2023
- Study start3 Jan 2023
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center, Saint Vincent's Hospital, Korea, Seoul National University Hospital, Chungnam National University Hospital, Soonchunhyang University Cheonan Hospital
- 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
- NCT05733156
- Sponsor's protocol ID
- SCHUH 2022-10-003
- Acronym
- KROG22-11
- Status last verified
- Dec 2024
- First submitted
- 12 Jan 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li H, Kwon J, Kim HJ, Kim BH. Immune-modulatory effects of low-dose radiotherapy through macrophage polarization and transcriptional rewiring in triple-negative breast cancer. Biochem Biophys Res Commun. 2025 Oct 30;786:152711. doi: 10.1016/j.bbrc.2025.152711. Epub 2025 Sep 26.
PubMed 41046657
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. 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 Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy: a Multicenter, Single-arm Clinical Study (KROG 22-11)
- ClinicalTrials.gov ID
- NCT05733156
- Acronym / sponsor ID
- KROG22-11 / SCHUH 2022-10-003
- Conditions
- Neoplasms, Secondary Malignant Neoplasm
- Keywords
- Neoplasm Metastasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center, Saint Vincent's Hospital, Korea, Seoul National University Hospital, Chungnam National University Hospital, Soonchunhyang University Cheonan Hospital
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 17 Feb 2023 (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.
Recently, MD Anderson Cancer Center reported the phase II trial to investigate high-dose radiotherapy (HDRT, 20-70 Gy) and low-dose radiotherapy (LDRT, 1-10 Gy) for metastatic cancer patients who had undergone immunotherapy. HDRT or HDRT+LDRT was conducted in two respective groups and the treatment group was determined according to the disease status of participants, not randomization. Immunotherapy was maintained in this clinical study. Therefore, we aim to investigate this abscopal effect from adding LDRT to HDRT, irrespective of previous immunotherapy, in this multicenter, single-arm study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT + LDRT | Experimental | Radiation: SBRT + LDRT |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who can provide their 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 (three fractions) for extracranial metastases
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 + LDRTStereotactic body radiotherapy (SBRT) and low-dose radiotherapy (LDRT) are administered concurrently. SBRT is administered three times, at intervals of 1-2 days, and patients are treated with LDRT along with SBRT. LDRT is planned to irradiate EQD2 6 Gy considering the scattered dose caused by SBRT. | Radiation | SBRT + LDRT |
Primary outcome
Abscopal effect rate of low-dose radiotherapy lesions
Time frame: 3 months after completion of radiotherapy
The proportion of patients with an abscopal response of low-dose radiotherapy lesions assessed by RECIST v1.1
6 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
Progression-free survival rate
Time frame: 12 months after completion of radiotherapy
Overall survival rate
Time frame: 12 months after completion of radiotherapy
Adverse event
Time frame: 12 months after completion of radiotherapy
Immune cell subsets of peripheral blood and tissue samples
Time frame: 1 and 3 months after completion of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Derived from this study: PubMed 41046657Li H, Kwon J, Kim HJ, Kim BH. Immune-modulatory effects of low-dose radiotherapy through macrophage polarization and transcriptional rewiring in triple-negative breast cancer. Biochem Biophys Res Commun. 2025 Oct 30;786:152711. doi: 10.1016/j.bbrc.2025.152711. Epub 2025 Sep 26.
- Individual participant dataSharing planned: No
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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.
Ah Ram Chang, MD, PhD study chair
Soonchunhayng Universtiy Seoul Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT + LDRT in people with Neoplasms and Secondary Malignant Neoplasm, run by Soonchunhyang University Hospital at 2 sites in South Korea.
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 9 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jae Sik Kim, MD (+82-2-709-3254, icarusky@schmc.ac.kr), or a site near the patient. 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?
On the ClinicalTrials.gov record for NCT05733156, which also lists 1 linked publication.
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 10 Dec 2024.