Status:
RECRUITING
Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Stage I Renal Cell Cancer
Stage II Renal Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the safety and feasibility of renal interstitial radiation therapy (interstitial brachytherapy). (Safety Lead-In) II. To evaluate local control of renal interstiti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04473781
Start Date
July 16 2020
End Date
June 30 2027
Last Update
July 29 2025
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095