Clinical trial · Interventional
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
NCT06467097CI-TRIAL-00078084SABLORrecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Neoplasm | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT(Stereotatic Body Radiation Therapy) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- A group
- description
- Only standard treatment is administered. The standard treatment includes targeted cancer therapy, immunotherapy, or monotherapy with each therapeutic agent.
- type
- EXPERIMENTAL
- label
- B group
- description
- This group receives concurrent partial nephrectomy radiotherapy for all metastatic lesions in addition to standard treatment.
- interventionNames
- Radiation: SBRT(Stereotatic Body Radiation Therapy)
Primary outcomes (1)
- measure
- 1-year progression-free survival rate
- timeFrame
- One year after completion of enrollment
- description
- Compare free survival between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.