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Abscopal Effect From Low-dose Radiotherapy in Metastatic Cancer Combined With Stereotactic Body Radiotherapy

Primary Purpose

Neoplasms, Secondary Malignant Neoplasm

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

SBRT + LDRT

SBRT alone

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring Neoplasm Metastasis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Randomization study: Patients who can provide their written informed consent
Cohort study: Patients who do not consent to randomization and who are able to consent to a prospective cohort study and provide written informed consent
Age ≥19 years
Patients with histologically confirmed primary solid cancer and who are planning to treat metastatic cancer
Patients with ECOG performance status 0-2
Patients planning stereotactic body radiotherapy for extracranial metastases
Based on RECIST v1.1, patients with at least one extracranial measurable lesion other than SBRT lesions
Patients with hematologic function suitable for radiotherapy (absolute neutrophil count ≥1,500/mm^3, hemoglobin ≥9 g/dL, platelet count ≥100,000/mm^3)
In the case of brain metastases, patients who do not have any ongoing neurological symptoms and who have stable brain metastases after local treatment (brain metastases are excluded from the measurable lesions)
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 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 (eg, allergic disease, radiation pneumonitis, etc.)
Patients with an 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
Patients with a history of symptomatic heart failure, myocardial infarction, unstable angina, severe arrhythmias, and uncontrolled chronic lung disease within 6 months of enrollment

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SBRT+LDRT

SBRT alone

Arm Description

In the experimental group, stereotactic body radiotherapy (SBRT) and low-dose radiotherapy (LDRT) are administered concurrently. SBRT is administered three times, at intervals of 1-2 days, with LDRT. LDRT is planned to irradiate EQD2 6 Gy considering the scattered dose caused by SBRT.

In the control group, stereotactic body radiotherapy (SBRT) alone is performed. SBRT is administered three times, at intervals of 1-2 days. The scattered dose should not exceed EQD2 2Gy to the non-irradiated lesion.

Outcomes

Primary Outcome Measures

Abscopal effect rate of low-dose radiotherapy lesions

Secondary Outcome Measures

Abscopal effect rate of low-dose radiotherapy lesions

Overall response rate

Full Information

NCT ID

NCT05578274

First Posted

September 27, 2022

Last Updated

April 11, 2023

Sponsor

Soonchunhyang University Hospital

Collaborators

SMG-SNU Boramae Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05578274

Brief Title

Abscopal Effect From Low-dose Radiotherapy in Metastatic Cancer Combined With Stereotactic Body Radiotherapy

Official Title

Abscopal Effect From the Addition of Low-dose Radiotherapy in Metastatic Cancer Patients Receiving Stereotactic Body Radiotherapy: a Multicenter, Randomized Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 2023 (Anticipated)

Primary Completion Date

January 2026 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Soonchunhyang University Hospital

Collaborators

SMG-SNU Boramae Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Stereotactic body radiotherapy (SBRT) has been known to enhance the abscopal effect by up to 40% when delivered with immune checkpoint inhibitors (ICIs). Recently, preclinical and clinical studies demonstrate that metastatic lesions treated with non-cytotoxic low-dose radiotherapy (LDRT) significantly were reduced in the condition where SBRT and ICIs were administered together. Given that ICIs are highly expensive and some tumors are beyond the indications of ICIs, novel approaches are required to boost the abscopal effect in the absence of ICIs. Therefore, the investigators design a multicenter, randomized clinical trial that investigates the efficacy and safety of LDRT combined with SBRT in metastatic cancer patients. The primary endpoint is a lesion-specific response of LDRT lesions (i.e., abscopal effect) evaluated three months after radiotherapy. Subjects will be randomly allocated into two groups (1:1) with the stratification by planning target volume and previous use of ICIs: control group (SBRT in three fractions) or experimental group (SBRT + LDRT in three factions). Unless patients agree with randomization, subjects will participate in a prospective cohort study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasms, Secondary Malignant Neoplasm

Keywords

Neoplasm Metastasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SBRT+LDRT

Arm Type

Experimental

Arm Description

Arm Title

SBRT alone

Arm Type

Active Comparator

Arm Description

Intervention Type

Radiation

Intervention Name(s)

SBRT + LDRT

Intervention Description

SBRT is performed according to the protocol of each institution. However, the total fraction of SBRT is fixed to 3, and the treatment interval is maintained for 1-2 days. The scattered dose should not exceed EQD2 (α/β=10) 2 Gy for non-irradiated lesions. LDRT is planned to irradiate EQD2 (α/β=10) 6 Gy to lesions, considering the scattered dose caused by SBRT. If there are non-irradiated lesions, they are defined as internal control, and the total dose is limited to 0.5 Gy or less. CTV allows up to 5 mm margin for GTV, and 3-10mm for PTV margin from CTV. It is planned that the iso-dose line corresponding to the prescribed dose contains at least 90% of PTV and 95% of GTV.

Intervention Type

Radiation

Intervention Name(s)

SBRT alone

Intervention Description

Primary Outcome Measure Information:

Title

Abscopal effect rate of low-dose radiotherapy lesions

Time Frame

3 months after completion of radiotherapy

Secondary Outcome Measure Information:

Title

Abscopal effect rate of low-dose radiotherapy lesions

Time Frame

1, 6, and 12 months after completion of radiotherapy

Title

Overall response rate

Time Frame

1, 3, 6, and 12 months after completion of radiotherapy

Other Pre-specified Outcome Measures:

Title

Progression-free survival rate

Time Frame

12 months after completion of radiotherapy

Title

Overall survival rate

Time Frame

12 months after completion of radiotherapy

Title

Adverse event

Time Frame

up to 12 months after completion of radiotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Randomization study: Patients who can provide their written informed consent Cohort study: Patients who do not consent to randomization and who are able to consent to a prospective cohort study and provide 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 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.) 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jae Sik Kim, MD

Phone

+82-2-709-3254

icarusky@schmc.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ah Ram Chang, MD, PhD

Organizational Affiliation

Soonchunhayng Universtiy Seoul Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

Abscopal Effect From Low-dose Radiotherapy in Metastatic Cancer Combined With Stereotactic Body Radiotherapy

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