Abscopal Effect from the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy (KROG22-11)

Soon Chun Hyang University

Status

Enrolling

Conditions

Neoplasms

Secondary Malignant Neoplasm

Treatments

Radiation: SBRT + LDRT

Study type

Interventional

Funder types

Other

Identifiers

NCT05733156

SCHUH 2022-10-003

Details and patient eligibility

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.

Enrollment

52 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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