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.
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 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
Single group
SBRT + LDRT
RadiationStereotactic 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.
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
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
Overall response rate
The proportion of patients showing complete or partial response of metastatic lesions
Progression-free survival rate
From the date of enrollment to the date of progression or death assessed by RECIST v1.1
Overall survival rate
From the date of enrollment to the date of death or last follow-up assessed by RECIST v1.1
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Soonchunhyang University Hospital
Lead sponsor
SMG-SNU Boramae Medical Center
Collaborator
Saint Vincent's Hospital, Korea
Collaborator
Seoul National University Hospital
Collaborator
Chungnam National University Hospital
Collaborator
