Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04473781

Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer

Led by Jonsson Comprehensive Cancer Center · Updated on 2026-03-02

17

Participants Needed

1

Research Sites

362 weeks

Total Duration

On this page

AI-Summary

What this Trial 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). 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.

CONDITIONS

Official Title

Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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