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Trial Title:
Abscopal Effect From the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy
NCT ID:
NCT05733156
Condition:
Neoplasms
Secondary Malignant Neoplasm
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Neoplasm Metastasis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
SBRT + LDRT
Description:
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.
Arm group label:
SBRT + LDRT
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Byoung Hyuck Kim, MD, PhD
Phone:
+82-2-870-1683
Email:
karlly71@hanmail.net
Facility:
Name:
Soonchunhyang University Seoul Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Jae Sik Kim, MD
Phone:
+82-2-709-3254
Email:
myicarusky@gmail.com
Start date:
January 3, 2023
Completion date:
June 2026
Lead sponsor:
Agency:
Soonchunhyang University Hospital
Agency class:
Other
Collaborator:
Agency:
SMG-SNU Boramae Medical Center
Agency class:
Other
Collaborator:
Agency:
Saint Vincent's Hospital, Korea
Agency class:
Other
Collaborator:
Agency:
Seoul National University Hospital
Agency class:
Other
Collaborator:
Agency:
Chungnam National University Hospital
Agency class:
Other
Source:
Soonchunhyang University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05733156
