Abscopal effect from the addition of low-dose radiotherapy in metastatic cancer patients receiving stereotactic body radiotherapy: a multicenter, randomized clinical study

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0007755
• Lead Sponsor: Soon Chun Hyang University Hospital Seoul

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abscopal effect rate of low-dose radiotherapy lesions

Secondary Outcome Measures

Name	Time	Method
Abscopal effect rate of low-dose radiotherapy lesions;Overall response rate;Progression-free survival rate;Overall survival rate;Adverse event