None listed
Conditions
Interventions
Radiation : 1)Control group: A group that undergoes standard treatment alone for metastatic renal cell carcinoma. 2)Experimental group: A group that receives concurrent partial nephrectomy radiotherap
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Risk ratio of every study participants after radiation completion of one- year progression-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| The amount of time till progressive disease;Local control rate for radiation therapy site at one year;Grade 3 acute adverse event;Grade 3 chronic adverse event;Overall survival rate | — |
Countries
Korea, Republic of
Contacts
Public ContactSumin Ryoo
Samsung Medical Center
Outcome results
None listed