RecruitingPhase 1

Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer

United States17 participantsStarted 2020-07-16

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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-r…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose limiting toxicity (DLT)

Timeframe: From the first administration of study therapy up to 60 days

One year (12-month) linear growth rate

Timeframe: At 1 year

Trial details

NCT IDNCT04473781

SponsorJonsson Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Stage I Renal Cell Cancer trials