NCT04473781 · Jonsson Comprehensive Cancer Center
Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer
What this study is about
This phase I/II trial investigates the side effects of interstitial brachytherapy and to see how well it works in limiting the growth of large kidney cancer masses in patients with kidney cancer that have refused or are unable to undergo surgery or ablation (unresectable/unablatable).
View original scientific description
This phase I/II trial investigates the side effects of interstitial brachytherapy and to see how well it works in limiting the growth of large kidney cancer masses in patients with kidney cancer that have refused or are unable to undergo surgery or ablation (unresectable/unablatable). Brachytherapy, also known as internal radiation therapy, temporarily introduces a radiation source into or near the tumor to eradicate the tumor cells. Giving brachytherapy may potentially reduce the size of the kidney cancer mass that would otherwise not be amenable to surgical management and translate into lower risk of spread.
Interventions
PROCEDURE
Interstitial Radiation Therapy
Undergo interstitial brachytherapy
Primary outcome measures
Dose limiting toxicity (DLT)
Time frame: From the first administration of study therapy up to 60 days
A 3+3 safety lead-in phase will be employed in order to determine the DLT for interstitial renal brachytherapy. Grading of DLTs will follow the guidelines provided in the Common Terminology Criteria for Adverse Events version 5.0 criteria.
One year (12-month) linear growth rate
Time frame: At 1 year
Adequate local control will be defined as minimal growth kinetics (=\< 1 mm/year) on 1 year follow-up.
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
- Elected to undergo interstitial brachytherapy as part of conventional treatment for renal cell carcinoma
- Biopsy proven renal cell carcinoma
- No definitive evidence of locally advanced (nodal or tumor thrombus) or distant (metastatic) disease
- Lesion size (maximal dimension) of 4 to 10 cm
- Patient not a candidate for curative surgery (unwilling or unable to pursue surgery)
- Lesion cannot be reliably treated with ablative techniques
- Entire lesion able to be treated adequately by brachytherapy per radiation oncologist
- Tumor predominantly solid (\~ \> 80%)
- Lesion that has been observed for \>= 6 months with demonstrable growth rate anticipated to be \>= 4 mm/year by same imaging modality
- Renal tumor that is amenable to percutaneous access for interstitial renal brachytherapy (Institutional Review Board \[IRB\])
- Hemoglobin \> 9
- Absolute neutrophil count (ANC) \>= 1500/uL (microliter)
- Platelets \>= 100,000/uL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 upper limit of normal (ULN)
- Total bilirubin =\< ULN
- A competent immune system
- Estimated glomerular filtration rate (eGFR) \>= 30
- Good performance status (Eastern Cooperative Oncology Group \[ECOG\]) \< 2
- Understanding and willingness to provide consent
- No prior systemic treatment for kidney cancer
- Women of childbearing potential must have negative pregnancy test at start of therapy
Exclusion criteria
- Presence of an active, untreated, non-renal malignancy
- Uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction within 6 months
- History of bleeding diathesis or recent bleeding episode
- Need for urgent treatment of renal cancer due bleeding, pain, or paraneoplastic syndrome
- Prior surgery or radiation therapy to the operative site
- Unwillingness to undergo clinical and laboratory monitoring and/or imaging studies
Where
- Los Angeles, California
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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 Mar 2, 2026 · Source of record for eligibility and locations