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

RecruitingNAAges 19 Years - anyAllSoonchunhyang University Hospital
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients who can provide their written informed consent * Age โ‰ฅ19 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 โ‰ฅ1,500/mm\^3, hemoglobin โ‰ฅ9 g/dL, platelet count โ‰ฅ100,000/mm\^3) * Patients with a life expectancy of 6 months or more according to the researcher's judgment Exclusion Criteria: * Patients participating in other clinical studies that may affect the efficacy/safety of 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 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
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What it tests

  • SBRT + LDRT
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Where

2 sites
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, South Korea
Soonchunhyang University Seoul Hospital
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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