RecruitingPhase 3NCT06467097
Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma
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
Sponsor
Samsung Medical Center
Enrollment
88 participants
Start Date
Apr 16, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 20 YearsMax Age: 80 Years
Inclusion Criteria11
- 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.
Exclusion Criteria8
- Patients with total bilirubin \> 3.6 mg/dL.
- Patients with AST \>160 U/L, ALT \> 165 U/L.
- Patients unable to maintain position for partial nephrectomy radiotherapy.
- Patients with a history of radiotherapy to metastatic renal cell carcinoma or surrounding areas.
- Patients with confirmed brain, peritoneal, or pleural metastases.
- Patients diagnosed with another solid tumor and treated within 2 years or with residual lesions.
- Patients who do not consent to participate in the study.
- Pregnant patients.
Interventions
RADIATIONSBRT(Stereotatic Body Radiation Therapy)
Patients will receive treatment for one to two weeks, one to five times per region.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06467097
Related Trials
The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry
NCT023464351 location
Clinical Trial Addressing the Best Surgical Approach for Partial Nephrectomy With Single Port Robotic System in the Management of Localized Renal Cell Carcinoma
NCT072344091 location
Primary Tumor Ablation and Outcome in Metastatic Renal Cell Carcinoma Treated With Immunotherapy Combinations.
NCT069033121 location
Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer
NCT048239235 locations
German National Registry for NSS
NCT046816905 locations