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

Neoplasms Clinical Trial

— KROG22-11  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733156
• Other study ID #: SCHUH 2022-10-003
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Soonchunhyang University Hospital
• Contact: Jae Sik Kim, MD
• Phone: +82-2-709-3254
• Email: icarusky[@]schmc.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Secondary Malignant Neoplasm

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Soonchunhyang University Seoul Hospital	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital	Chungnam National University Hospital, Saint Vincent's Hospital, Korea, Seoul National University Hospital, SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse event	The proportion of patients with treatment-related adverse events as assessed by CTCAE v5.0	12 months after completion of radiotherapy
Secondary	Immune cell subsets of peripheral blood and tissue samples	Number of immune cell count	1 and 3 months after completion of radiotherapy