Abscopal Effect From the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy (KROG22-11)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Secondary Malignant Neoplasm
• Intervention / Treatment: Radiation: SBRT + LDRT

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jae Sik Kim, MD; Phone Number: +82-2-709-3254; Email: icarusky@schmc.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul Metropolitan Government Seoul National University Boramae Medical Center
    • Contact: Byoung Hyuck Kim, MD, PhD; Phone Number: +82-2-870-1683; Email: karlly71@hanmail.net
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • SoonChunHyang University Seoul Hospital
    • Contact: Jae Sik Kim, MD; Phone Number: +82-2-709-3254; Email: myicarusky@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBRT + LDRT	Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abscopal effect rate of low-dose radiotherapy lesions	The proportion of patients with an abscopal response of low-dose radiotherapy lesions assessed by RECIST v1.1	3 months after completion of radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abscopal effect rate of low-dose radiotherapy lesions	The proportion of patients with an abscopal response of low-dose radiotherapy lesions assessed by RECIST v1.1	1, 6, and 12 months after completion of radiotherapy
Overall response rate	The proportion of patients showing complete or partial response of metastatic lesions	1, 3, 6, and 12 months after completion of radiotherapy
Progression-free survival rate	From the date of enrollment to the date of progression or death assessed by RECIST v1.1	12 months after completion of radiotherapy
Overall survival rate	From the date of enrollment to the date of death or last follow-up assessed by RECIST v1.1	12 months after completion of radiotherapy
Adverse event	The proportion of patients with treatment-related adverse events as assessed by CTCAE v5.0	12 months after completion of radiotherapy
Immune cell subsets of peripheral blood and tissue samples	Number of immune cell count	1 and 3 months after completion of radiotherapy

Collaborators and Investigators

• Sponsor: Soonchunhyang University Hospital
• Collaborators: Seoul National University Hospital; SMG-SNU Boramae Medical Center; Saint Vincent's Hospital, Korea; Chungnam National University Hospital
• Investigators: Study Chair: Ah Ram Chang, MD, PhD, Soonchunhayng Universtiy Seoul Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Neoplasm Metastasis
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SCHUH 2022-10-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No