Abscopal Effect From the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy

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.

Inclusion Criteria:Patients who can provide their written informed consentAge ≥19 yearsPatients with histologically confirmed primary solid (irrespective of the status of the primary tumor)Patients with ECOG performance status 0-2Patients planning stereotactic body radiotherapy (three fractions) for extracranial metastasesBased on RECIST v1.1, patients with at least one extracranial measurable lesion other than SBRT lesionsPatients 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 judgmentExclusion Criteria:Patients participating in other clinical studies that may affect the efficacy/safety of this clinical studyPatients with brain metastasisPatients planning SBRT for all measurable lesions due to oligometastasisPatients with a history of radiotherapy for extracranial metastases within 3 months of the enrollmentPatients unable to cooperate with stereotactic body radiotherapyPatients who are pregnant or planning toPatients 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