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Recruiting Not applicable

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

NCT05733156 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2023-01-03
Last updated
2024-12-10

Condition(s) studied

NeoplasmsSecondary Malignant Neoplasm

Investigational drug(s) / intervention(s)

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.

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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 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

Primary outcome measure(s)

  • Abscopal effect rate of low-dose radiotherapy lesions — 3 months after completion of radiotherapy
    The proportion of patients with an abscopal response of low-dose radiotherapy lesions assessed by RECIST v1.1

Trial sites (2)

FacilityCityRegionStatus
Seoul Metropolitan Government Seoul National University Boramae Medical Center Seoul South Korea Recruiting
Soonchunhyang University Seoul Hospital Seoul South Korea Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05733156 on ClinicalTrials.gov ↗ ← All trials in South Korea