Clinical trial NCT05733156: Abscopal Effect from the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy
Official title: Abscopal Effect from the Addition of Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy: a Multicenter, Single-arm Clinical Study (KROG 22-11)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Secondary Malignant Neoplasm
Keywords: Neoplasm Metastasis
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
name: Catholic University of Korea, St. Vincent Hospital
name: Seoul National University Hospital
name: Chungnam National University Hospital
First posted: 2023-02-17
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Abscopal effect rate of low-dose radiotherapy lesions
timeFrame: 3 months after completion of radiotherapy
Secondary outcomes:
measure: Abscopal effect rate of low-dose radiotherapy lesions
timeFrame: 1, 6, and 12 months after completion of radiotherapy
measure: Overall response rate
timeFrame: 1, 3, 6, and 12 months after completion of radiotherapy
measure: Progression-free survival rate
timeFrame: 12 months after completion of radiotherapy
measure: Overall survival rate
timeFrame: 12 months after completion of radiotherapy
measure: Adverse event
timeFrame: 12 months after completion of radiotherapy
measure: Immune cell subsets of peripheral blood and tissue samples
timeFrame: 1 and 3 months after completion of radiotherapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Seoul Hospital
Study officials:
affiliation: Soonchunhayng Universtiy Seoul Hospital
name: Ah Ram Chang, MD, PhD
role: STUDY_CHAIR
References: