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

A Phase Ⅲ Randomized Study Systemic Treatment Alone Versus Systemic Treatment Plus Stereotactic Abative Body Radiotherapy for Patients With Oligometastatic Renal Cell Carcinoma: SABLOR Study

This study is testing if adding targeted radiation therapy to regular treatment can help people with kidney cancer that has spread a little to live longer without their cancer getting worse.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Samsung Medical Center (Academic / other)
• Locations: 1 site (Seoul)
• Trial ID: NCT06467097 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients aged 20 to 80 with clear cell renal carcinoma and up to 5 metastases who have undergone or are scheduled for surgery.

Not a fit: Patients with more than 5 metastases or those with poor organ function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that significantly improves progression-free survival for patients with oligometastatic renal cell carcinoma.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific combination is still being evaluated for its efficacy.

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.

Where this trial is running

Seoul

• Samsung Medical Center — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Won Park, M.D., Ph.D.

Conditions Kidney Neoplasm