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
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.
• 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.
• Patients aged 20 to 80 years.
• Patients with individual metastases ≤ 5 cm in longest diameter.
• Patients with primary tumors surgically removed or scheduled for surgery.
• Patients histologically diagnosed with clear cell carcinoma.
• Patients with ECOG performance status 0-1.
• 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.
• Patients who understand the contents of the informed consent form, voluntarily consent to participate in the study, and sign the informed consent form.
• Patients who agree to use contraception from the time of signing the consent form until 1 year after the last standard systemic therapy.
⁃ Breastfeeding women who agree to stop breastfeeding for at least 5 months after the last standard systemic therapy.
⁃ Patients with visible tumors outside the scope of tumor removal surgery (surgical therapy) for metastatic lesions.