Abscopal Effect from the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy
NCT ID: NCT05733156
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
52 participants
INTERVENTIONAL
2023-01-03
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SBRT + LDRT
SBRT + LDRT
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.
Interventions
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SBRT + LDRT
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.
Eligibility Criteria
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Inclusion Criteria
* 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 planning stereotactic body radiotherapy (three fractions) for extracranial metastases
* Based on RECIST v1.1, patients with at least one extracranial measurable lesion other than SBRT lesions
* Patients 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 judgment
Exclusion Criteria
* 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
* 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 therapy within 2 weeks of enrollment - Patients with an (e.g. allergic disease, radiation pneumonitis, etc.) (The use of steroids for preventive purposes is allowed (e.g., to prevent vomiting during chemotherapy)) 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
19 Years
ALL
No
Sponsors
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SMG-SNU Boramae Medical Center
OTHER
Catholic University of Korea, St. Vincent Hospital
UNKNOWN
Seoul National University Hospital
OTHER
Chungnam National University Hospital
OTHER
Soonchunhyang University Hospital
OTHER
Responsible Party
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Ah Ram Chang
Director of Radiation Oncology
Principal Investigators
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Ah Ram Chang, MD, PhD
Role: STUDY_CHAIR
Soonchunhayng Universtiy Seoul Hospital
Locations
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Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, , South Korea
Soonchunhyang University Seoul Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Byoung Hyuck Kim, MD, PhD
Role: primary
Jae Sik Kim, MD
Role: primary
Other Identifiers
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SCHUH 2022-10-003
Identifier Type: -
Identifier Source: org_study_id