NCT06467097 Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma
| NCT ID | NCT06467097 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Samsung Medical Center |
| Condition | Kidney Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2024-04-16 |
| Primary Completion | 2031-02-13 |
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.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 88 participants in total. It began in 2024-04-16 with a primary completion date of 2031-02-13.
⚠ 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
To evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients.
Eligibility Criteria
Inclusion Criteria: 1. Patients with metastatic renal cell carcinoma classified within the ESTRO/EORTC classification system as having ≤ 5 metastases, ≤ 3 metastatic organs, and meeting criteria for new, recurrent, or induced metastases. 2. Patients aged 20 to 80 years. 3. Patients with individual metastases ≤ 5 cm in longest diameter. 4. Patients with primary tumors surgically removed or scheduled for surgery. 5. Patients histologically diagnosed with clear cell carcinoma. 6. Patients with ECOG performance status 0-1. 7. Patients with normal major organ function and bone marrow function meeting specific criteria: WBC ≥ 2,000/μL, neutrophils ≥ 1,000/μL, platelets ≥ 50,000/μL. 8. Patients who understand the contents of the informed consent form, voluntarily consent to participate in the study, and sign the informed consent form. 9. Patients who agree to use contraception from the time of signing the consent form until 1 year after the last standard systemic therapy. 10. Breastfeeding women who agree to stop breastfeeding for at least 5 months after the last standard systemic therapy. 11. Patients with visible tumors outside the scope of tumor removal surgery (surgical therapy) for metastatic lesions. Exclusion Criteria: 1. Patients with total bilirubin \> 3.6 mg/dL. 2. Patients with AST \>160 U/L, ALT \> 165 U/L. 3. Patients unable to maintain position for partial nephrectomy radiotherapy. 4. Patients with a history of radiotherapy to metastatic renal cell carcinoma or surrounding areas. 5. Patients with confirmed brain, peritoneal, or pleural metastases. 6. Patients diagnosed with another solid tumor and treated within 2 years or with residual lesions. 7. Patients who do not consent to participate in the study. 8. Pregnant patients.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06467097 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Kidney Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06467097 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 88 participants.
Is NCT06467097 currently recruiting?
Yes, NCT06467097 is actively recruiting participants. Contact the research team at wonro.park@samsung.com for enrollment information.
Where is the NCT06467097 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06467097 clinical trial?
NCT06467097 is sponsored by Samsung Medical Center. The trial plans to enroll 88 participants.
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