Comparing systemic treatment alone to systemic treatment with added radiotherapy for kidney cancer with few metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III clinical trial aims to evaluate the effectiveness of adding locoregional radiotherapy to standard systemic therapy in patients with oligometastatic renal cell carcinoma. The study focuses on patients with a limited number of metastases and assesses whether this combination can improve progression-free survival rates compared to systemic treatment alone. Participants will receive stereotactic body radiation therapy (SBRT) alongside their standard treatment. The trial seeks to determine if this approach can lead to better oncologic outcomes for patients with this specific type of cancer.

Why it matters

Who can join: the full rules

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.

Where it's running

• Samsung Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Won Park, M.D., Ph.D.
• Email: wonro.park@samsung.com
• Phone: +82-2-3410-2616

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.