NCT05733156 Abscopal Effect from the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy
| NCT ID | NCT05733156 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Soonchunhyang University Hospital |
| Condition | Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2023-01-03 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2023-01-03 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Ah Ram Chang, MD, PhD
STUDY CHAIR
Soonchunhayng Universtiy Seoul Hospital
Frequently Asked Questions
Who can join the NCT05733156 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05733156 currently recruiting?
Yes, NCT05733156 is actively recruiting participants. Contact the research team at icarusky@schmc.ac.kr for enrollment information.
Where is the NCT05733156 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT05733156 clinical trial?
NCT05733156 is sponsored by Soonchunhyang University Hospital. The principal investigator is Ah Ram Chang, MD, PhD at Soonchunhayng Universtiy Seoul Hospital. The trial plans to enroll 52 participants.