Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma

Recruiting now · Phase 3

Conditions studied: Kidney Neoplasm

In brief

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.

Key facts

Study ID

NCT06467097

Run by

Samsung Medical Center

People needed

88

Starts

2024-04-16

Expected to finish

2031-02-13

Last updated by the study team

2024-06-20

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.