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Compares treatment options for Kidney Neoplasm
Official title Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT06467097
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 80
You may be able to join if
- Patients with metastatic renal cell carcinoma classified within the ESTRO/EORTC classification system as having ≤ 5 metastases, ≤ 3 metastatic...
- 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.
You likely can't join 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.