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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
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.
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, South Korea
RECRUITINGSoonchunhyang University Seoul Hospital
Seoul, South Korea
NOT_YET_RECRUITINGAbscopal 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
Time frame: 3 months after completion of radiotherapy
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
Time frame: 1, 6, and 12 months after completion of radiotherapy
Overall response rate
The proportion of patients showing complete or partial response of metastatic lesions
Time frame: 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
Time frame: 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
Time frame: 12 months after completion of radiotherapy
Adverse event
The proportion of patients with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 12 months after completion of radiotherapy
Immune cell subsets of peripheral blood and tissue samples
Number of immune cell count
Time frame: 1 and 3 months after completion of radiotherapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.