NCT06376669 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma
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What this study is about
This study examines the impact of proton based stereotactic radiation therapy (SBRT) on kidney function as well as other oncologic outcomes including local control, locoregional and systemic failure, progression free and how long patients live.
View original scientific description
This study examines the impact of proton based stereotactic radiation therapy (SBRT) on kidney function as well as other oncologic outcomes including local control, locoregional and systemic failure, progression free and overall survival.
Interventions
RADIATION
Proton Stereotactic Body Radiation therapy (SBRT)
Radiation therapy will consist of 3-5 treatments over 1.5 - 2 weeks
Primary outcome measures
Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels
Time frame: Baseline and every 3-6 months up to 2 years post treatment
Change in serum creatine levels from Baseline visit.
Change in kidney function after PROTON-BASED SBRT treatment as assessed by estimated glomerular rate (eGFR) values
Time frame: Baseline and every 3-6 months up to 2 years post treatment
Change in eGFR values from Baseline visit.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥ 18 years
- Biopsy proven renal cell carcinoma.
- No clinical or radiographic evidence of metastatic disease.
- Not a candidate for surgical treatment or local ablative procedures.
- Subjects are able to undergo either an MRI or administration of contrast agent for CT.
Exclusion criteria
- Prior history of radiation treatment with overlapping fields.
- Patients with proven metastatic disease.
- Female subjects who are pregnant or planning to become pregnant during the treatment.
Where
- Washington D.C., District of Columbia
Collaborators
Robert L. Sloan Fund for Cancer Research
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 3, 2026 · Source of record for eligibility and locations