Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer
Recruiting
Phase 1Interventional Study
Stage I Renal Cell CancerStage II Renal Cell Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
17 (estimated)
Sponsor
Jonsson Comprehensive Cancer Center · Other
Who this trial is looking for
This trial is looking for patients with specific types of kidney cancer that cannot be surgically removed. Participants will receive a treatment called brachytherapy to help shrink their tumors and may be monitored for side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with renal cell carcinoma.
I cannot have surgery or ablative treatment for my condition.
My tumor is between 4 to 10 cm in size.
I have not received any previous systemic treatment for kidney cancer.
I understand and am willing to give my consent.
I have a good performance status and can participate in monitoring.
I have a hemoglobin level above 9.
You may not be able to join if
I have an active, untreated cancer that is not in my kidneys.
I have had uncontrolled medical issues like infections or heart problems in the last 6 months.
I have experienced recent bleeding or have a history of bleeding disorders.
I need urgent treatment for my kidney cancer due to severe symptoms.
I have previously had surgery or radiation at the treatment site.
I am unwilling to undergo the required monitoring and imaging studies.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 th…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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…
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
Contacts
No contact information available.
What are you hoping to find?
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.