Abscopal Effect from Low-dose Radiotherapy in Metastatic Cancer Combined with Stereotactic Body Radiotherapy
NCT ID: NCT05578274
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
186 participants
INTERVENTIONAL
2025-06-30
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SBRT+LDRT
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.
SBRT + LDRT
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.
SBRT alone
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.
SBRT alone
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.
Interventions
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SBRT + LDRT
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.
SBRT alone
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
ALL
No
Sponsors
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SMG-SNU Boramae Medical Center
OTHER
Soonchunhyang University Hospital
OTHER
Responsible Party
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Ah Ram Chang
Director of Radiation Oncology
Principal Investigators
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Ah Ram Chang, MD, PhD
Role: STUDY_CHAIR
Soonchunhayng Universtiy Seoul Hospital
Central Contacts
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Other Identifiers
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SCHUH 2022-07-004-001
Identifier Type: -
Identifier Source: org_study_id