Actively Recruiting
Prospective Study of Interstitial Brachytherapy for UnresectableUnablatable T1bT2a Renal Masses
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-03-02
17
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating interstitial brachytherapy, a form of internal radiation therapy, for patients with large kidney cancer masses who cannot undergo surgery or ablation. The study aims to assess the safety and feasibility of this treatment and how well it controls tumor growth in these patients. This phase III trial also seeks to understand treatment response and identify biomarkers related to radiation resistance or sensitivity. Participants receive interstitial brachytherapy in 1 or 2 treatment sessions, called fractions, depending on their condition and tolerance. These fractions may be given on the same day or spaced over two weeks. After treatment, patients are monitored every three months for at least three years to observe tumor control and detect any side effects or disease progression. Throughout the study, participants undergo regular evaluations including imaging to measure tumor size and growth rate, blood tests to assess organ function and immune status, and safety monitoring for side effects. The main outcomes measured are dose-limiting toxicity within 60 days of treatment and tumor growth rate at one year. This careful follow-up helps researchers determine the treatments safety and effectiveness over time.
CONDITIONS
Brief Title
Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
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