NCT05733156 Abscopal Effect from the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy

Trial Parameters

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Patients who can provide their written informed consent * 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 participating in other clinical studies that may affect the efficacy/safety of this clinical

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