Actively Recruiting
A Phase 3 Randomized Study of Systemic Treatment Alone Versus Systemic Treatment Plus Stereotactic Ablative Body Radiotherapy for Oligometastatic Renal Cell Carcinoma
Led by Samsung Medical Center · Updated on 2024-06-20
88
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether adding locoregional radiotherapy to standard systemic therapy improves progression-free survival in patients with oligometastatic renal cell carcinoma, which means kidney cancer with a limited number of metastases. This phase III randomized study aims to clarify if high-dose radiotherapy targeting metastases can better control the disease compared to systemic therapy alone. The trial includes patients with specific metastatic profiles, including new, recurrent, or induced metastases, to evaluate oncologic outcomes more precisely. Participants are divided into two groups: one receives only standard systemic treatment, which may include targeted therapy, immunotherapy, or monotherapy with cancer drugs. The other group receives the same systemic treatment plus stereotactic ablative body radiotherapy (SBRT) directed at all metastatic lesions, typically given over one to two weeks with one to five sessions per region. This approach allows researchers to compare the effects of adding focused radiotherapy on disease progression. During the study, participants will be closely monitored through various assessments such as imaging and lab tests to track treatment effects and potential side effects. The main outcome measured is the one-year progression-free survival rate after completing enrollment. Additionally, researchers will evaluate local control at radiation sites, adverse events at different time points, and overall survival up to 36 months. The study's duration and follow-up ensure comprehensive data collection on treatment impact and safety.
CONDITIONS
Brief Title
Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with metastatic renal cell carcinoma having 5 or fewer metastases and 3 or fewer metastatic organs, including new, recurrent, or induced metastases
- Age between 20 and 80 years
- Individual metastases 5 cm or smaller in longest diameter
- Primary tumors surgically removed or planned for surgery
- Histologically confirmed clear cell carcinoma
- ECOG performance status of 0 or 1
- Normal major organ function and bone marrow function (WBC ≥ 2,000/μL, neutrophils ≥ 1,000/μL, platelets ≥ 50,000/μL)
- Ability to understand and voluntarily sign informed consent
- Agreement to use contraception from consent until 1 year after last systemic therapy
- Breastfeeding women agree to stop breastfeeding for at least 5 months after last systemic therapy
- Presence of visible tumors outside the scope of surgical removal for metastatic lesions
You will not qualify if you...
- Total bilirubin level greater than 3.6 mg/dL
- AST greater than 160 U/L or ALT greater than 165 U/L
- Inability to maintain position for partial nephrectomy radiotherapy
- History of radiotherapy to metastatic renal cell carcinoma or surrounding areas
- Confirmed brain, peritoneal, or pleural metastases
- Diagnosis of another solid tumor treated within 2 years or with residual lesions
- Lack of consent to participate in the study
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 weeks for radiotherapy plus systemic therapy duration as determined by standard treatment
Participants receive standard systemic therapy for metastatic renal cell carcinoma. Some participants also receive stereotactic ablative body radiotherapy (SBRT) targeting metastatic lesions concurrently with systemic therapy.
1 to 5 radiotherapy visits per region over 1 to 2 weeks; systemic therapy visits as per standard care
Duration - Up to 36 months
Participants are monitored for progression-free survival, local control of radiation sites, adverse events, and overall survival after treatment completion.
Regular follow-up visits including assessments at 3 to 6 months, 1 year, and up to 3 years after treatment
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
W
Won Park, M.D., Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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