Actively Recruiting
Abscopal Effect from the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy
Led by Soonchunhyang University Hospital · Updated on 2024-12-10
52
Participants Needed
2
Research Sites
177 weeks
Total Duration
On this page
Sponsors
S
Soonchunhyang University Hospital
Lead Sponsor
S
SMG-SNU Boramae Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Abscopal Effect from the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who can provide their written informed consent
- Age 6519 years
- Patients with histologically confirmed primary solid tumor (regardless of primary tumor status)
- ECOG performance status between 0 and 2
- Planning stereotactic body radiotherapy (three fractions) for extracranial metastases
- At least one extracranial measurable lesion other than SBRT targets based on RECIST v1.1
- One or more measurable lesions unsuitable for SBRT or palliative radiotherapy but eligible for LDRT (excluding bone metastases)
- Hematologic function adequate for radiotherapy (absolute neutrophil count 651,500/mm3, hemoglobin 659 g/dL, platelet count 65100,000/mm3)
- Life expectancy of 6 months or longer as judged by researcher
You will not qualify if you...
- Participation in other clinical studies affecting this study's efficacy or safety
- Presence of brain metastases
- Planning SBRT for all measurable lesions due to oligometastasis
- History of radiotherapy for extracranial metastases within 3 months before enrollment
- Inability to cooperate with stereotactic body radiotherapy
- Pregnancy or plans to become pregnant
- Advanced or multiple malignancies needing aggressive treatment (except certain skin cancers)
- Systemic steroid or immunosuppressive therapy within 2 weeks before enrollment
- Active autoimmune disease requiring systemic treatment in past 2 years or severe autoimmune disease
- Active infection requiring systemic treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, South Korea
Actively Recruiting
2
Soonchunhyang University Seoul Hospital
Seoul, South Korea
Not Yet Recruiting
Research Team
J
Jae Sik Kim, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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