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

NCT05733156 | Recruiting

• 1 other identifier: SCHUH 2022-10-003
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Neoplasms; Secondary Malignant Neoplasm

Keywords

Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Progression-free survival rate

  12 months after completion of radiotherapy

• Overall survival rate

  12 months after completion of radiotherapy

• Adverse event

  12 months after completion of radiotherapy

Study Arms (1)

SBRT + LDRT

EXPERIMENTAL

Radiation: SBRT + LDRT

Interventions

SBRT + LDRT RADIATION

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.

SBRT + LDRT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead
• SMG-SNU Boramae Medical Center: collaborator
• Saint Vincent's Hospital, Korea: collaborator
• Seoul National University Hospital: collaborator
• Chungnam National University Hospital: collaborator

Study Sites (2)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea

RECRUITING

Soonchunhyang University Seoul Hospital

Seoul, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms; Neoplasms, Second Primary; Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ah Ram Chang, MD, PhD

  Soonchunhayng Universtiy Seoul Hospital

  STUDY CHAIR

Central Study Contacts

Jae Sik Kim, MD

CONTACT

+82-2-709-3254; icarusky@schmc.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Radiation Oncology

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 17, 2023
• Study Start: January 3, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)