Combining low-dose and high-dose radiotherapy for metastatic cancer patients
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)
This study is testing if combining low-dose and high-dose radiotherapy can improve treatment outcomes for patients with metastatic cancer who are also receiving immunotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Soonchunhyang University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation, immunotherapy |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT05733156 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the potential abscopal effect of adding low-dose radiotherapy (LDRT) to high-dose radiotherapy (HDRT) in patients with polymetastatic cancer who are also receiving immunotherapy. The study is a multicenter, single-arm design where patients will undergo stereotactic body radiotherapy (SBRT) for their extracranial metastases, with the treatment group determined by disease status rather than randomization. Participants must have measurable lesions suitable for LDRT and meet specific eligibility criteria regarding their health and performance status. The aim is to evaluate the efficacy of this combined approach in enhancing treatment outcomes for metastatic cancer patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with histologically confirmed primary solid tumors and measurable extracranial lesions.
Not a fit: Patients with bone metastases not suitable for LDRT or those participating in other clinical studies may not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with metastatic cancer by leveraging the abscopal effect.
How similar studies have performed: Other studies have shown promise in utilizing similar approaches, but this specific combination of LDRT and HDRT in the context of immunotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul and 1 other locations
- Seoul Metropolitan Government Seoul National University Boramae Medical Center — Seoul, South Korea (Recruiting)
- Soonchunhyang University Seoul Hospital — Seoul, South Korea (Not_yet_recruiting)
Study contacts
- Study coordinator: Jae Sik Kim, MD
- Email: icarusky@schmc.ac.kr
- Phone: +82-2-709-3254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.