Abscopal Effect from the Addition of Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy: a Multicenter, Single-arm Clinical Study (KROG 22-11)

Soonchunhyang University Hospital2 sites in 1 country52 target enrollmentJanuary 3, 2023

ConditionsNeoplasms Secondary Malignant Neoplasm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neoplasms
Sponsor: Soonchunhyang University Hospital
Enrollment: 52
Locations: 2
Primary Endpoint: Abscopal effect rate of low-dose radiotherapy lesions
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 3, 2023

End Date

June 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Soonchunhyang University Hospital

Responsible Party

Principal Investigator

Ah Ram Chang

Director of Radiation Oncology

Soonchunhyang University Hospital

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 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

Outcomes

Primary Outcomes

Abscopal effect rate of low-dose radiotherapy lesions

Time Frame: 3 months after completion of radiotherapy

The proportion of patients with an abscopal response of low-dose radiotherapy lesions assessed by RECIST v1.1

Secondary Outcomes

Abscopal effect rate of low-dose radiotherapy lesions(1, 6, and 12 months after completion of radiotherapy)
Overall response rate(1, 3, 6, and 12 months after completion of radiotherapy)
Overall survival rate(12 months after completion of radiotherapy)
Adverse event(12 months after completion of radiotherapy)
Immune cell subsets of peripheral blood and tissue samples(1 and 3 months after completion of radiotherapy)
Progression-free survival rate(12 months after completion of radiotherapy)