Phase
Condition
Neoplasms
Treatment
SBRT + LDRT
Clinical Study ID
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients who can provide their written informed consent
Age ≥19 years
Patients with histologically confirmed primary solid (irrespective of the status ofthe primary tumor)
Patients with ECOG performance status 0-2
Patients planning stereotactic body radiotherapy (three fractions) for extracranialmetastases
Based on RECIST v1.1, patients with at least one extracranial measurable lesionother than SBRT lesions
Patients with one or more measurable lesions, which are not suitable for SBRT orpalliative radiotherapy and can be considered for LDRT (bone metastasis is notindicated for LDRT)
Patients with hematologic function suitable for radiotherapy (absolute neutrophilcount ≥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'sjudgment
Exclusion
Exclusion Criteria:
Patients participating in other clinical studies that may affect the efficacy/safetyof 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 monthsof the enrollment
Patients unable to cooperate with stereotactic body radiotherapy
Patients who are pregnant or planning to
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 therapywithin 2 weeks of enrollment - Patients with an (e.g. allergic disease, radiationpneumonitis, etc.) (The use of steroids for preventive purposes is allowed (e.g., toprevent vomiting during chemotherapy)) active autoimmune disease requiring systemictreatment within the past 2 years, evidence of clinically severe autoimmune disease,or syndrome requiring systemic steroid or immunosuppressive therapy (Patients whoneed intermittent use of bronchodilators, inhaled steroids, or topical steroidinjections, hypothyroid patients on stable hormone replacement therapy, type 1diabetes patients, or patients recovering from childhood asthma/atopic dermatitisare permitted)
Patients with active infection requiring systemic treatment
Study Design
Connect with a study center
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Soonchunhyang University Seoul Hospital
Seoul,
Korea, Republic ofSite Not Available
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