None listed
Conditions
Interventions
Radiation : Stereotactic body radiotherapy 24-30 Gy in 3 fractions to single lesion (8-10 Gy per fraction) every 2-3 days.
Low-dose radiotherapy 1-2 fractions (1.5-2.0 Gy per fraction) to half of meta
Sponsors
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. aged 19 years or older 2. histologically confirmed as malignant neoplasm 3. 3 or more measurable lesions according to RECIST1.1 4. needs treatment with immune checkpoint inhibitor per medical oncologist 5. suitable for stereotactic body radiotherapy per radiation oncologist 6. 1 or more extracranial lesion suitable for stereotactic body radiotherapy 7. adequate CBC/differential count as follows: absolute neutrophil count = 1,000/mm3; hemoglobin = 9 g/dL, platelet = 75,000/mm3) 8. in patients with brain metastases, the patient has to be neurologically stable with no progressive intracranial lesion after local treatment (surgery or radiotherapy) 9. has provided study-specific informed consent prior to study registration
Exclusion criteria
Exclusion criteria: 1. Eastern Cooperative Oncology Group performance 3 or 4 2. enrolled in another clinical trial evaluating drug or medical device 3. malignant cord compression or impending cord compression by metastatic lesion requiring urgent surgery or radiotherapy 4. impossible to comply to stereotactic body radiotherapy due to pain, neurology, or other underlying medical conditions 5. pregnant or has pregnancy plans 6. has synchronous malignancy requiring treatment other than the current metastatic cancer responsible for study enrollment (completely resected non-melanoma skin cancer with curative intent or carcinoma in situ are not included) 7. has received systemic steroid or other immunosuppressive therapy within 2 weeks prior to study enrollment 8. has undergone systemic treatment for active autoimmune disease within the prior 2 years, has current evidence of clinically severe autoimmune disease, or has other medical syndrome requiring systemic steroid or immunosuppression (patients requiring intermittent use of bronchodilator or steroid inhalation, and patients requiring local steroid injection are not included. Patients with stable hypothyroidism or type I diabetes treated with hormone replacement therapy, and patients who have recovered from pediatric type asthma/atopic dermatitis are also eligible for the study) 9. has active infection requiring systemic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;abscopal response;overall survival, progression-free survival;toxicity | — |
Countries
Korea, Republic of
Contacts
Public Contactyeongnan Choi
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Outcome results
None listed