Stage I Renal Cell CancerPhase 1NCT04473781
Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer
A Phase 1 study testing Interstitial Radiation Therapy in people with Stage I Renal Cell Cancer and Stage II Renal Cell Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Renal Cell Cancer, Stage II Renal Cell Cancer
- What is being tested?
- Interstitial Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2020to 4 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Prospective Study of Interstitial Brachytherapy for Unresectable/Unablatable T1b/T2a Renal Masses
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety and feasibility of renal interstitial radiation therapy (interstitial brachytherapy). (Safety Lead-In) II. To evaluate local control of renal interstitial brachytherapy. (Expansion Phase)
SECONDARY OBJECTIVES:
- To evaluate treatment response of the primary tumor. II. To evaluate 12 month distant progression free survival. III. To evaluate the 12 month volumetric growth of the primary tumor mass. IV. To determine biomarkers predicting response and resistance to radiation treatment.
OUTLINE:
Patients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both fractions in the same day or on 2 separate days over 2 weeks.
After completion of study treatment, patients are followed up every 3 months for at least 3 years.
- Being tested
- Interstitial Radiation Therapy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interstitial Radiation TherapyProcedure or surgery
Also called BRACHYTHERAPY, INTERSTITIAL, Implant Radiation
Undergo interstitial brachytherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (interstitial brachytherapy) | Experimental | Patients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both fractions in the same day or on 2 separate days over 2 weeks. Receives: Procedure: Interstitial Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
A 3+3 safety lead-in phase will be employed in order to determine the DLT for interstitial renal brachytherapy. Grading of DLTs will follow the guidelines provided in the Common Terminology Criteria for Adverse Events version 5.0 criteria.
Measured: From the first administration of study therapy up to 60 days
One year (12-month) linear growth rate
Adequate local control will be defined as minimal growth kinetics (=< 1 mm/year) on 1 year follow-up.
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start16 Jul 2020
- Primary completion4 Sep 2025
- Study completion4 Sep 2025
Why it stopped: slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albert J Chang, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473781
- Sponsor's protocol ID
- 19-001258
- Other IDs
- NCI-2020-04542
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Interstitial Brachytherapy for Unresectable/Unablatable T1b/T2a Renal Masses
- ClinicalTrials.gov ID
- NCT04473781
- Acronym / sponsor ID
- 19-001258
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow Accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety and feasibility of renal interstitial radiation therapy (interstitial brachytherapy). (Safety Lead-In) II. To evaluate local control of renal interstitial brachytherapy. (Expansion Phase)
SECONDARY OBJECTIVES:
- To evaluate treatment response of the primary tumor. II. To evaluate 12 month distant progression free survival. III. To evaluate the 12 month volumetric growth of the primary tumor mass. IV. To determine biomarkers predicting response and resistance to radiation treatment.
OUTLINE:
Patients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both fractions in the same day or on 2 separate days over 2 weeks.
After completion of study treatment, patients are followed up every 3 months for at least 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (interstitial brachytherapy) | Experimental | Procedure: Interstitial Radiation TherapyPatients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both fractions in the same day or on 2 separate days over 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interstitial Radiation TherapyAlso: BRACHYTHERAPY, INTERSTITIAL, Implant RadiationUndergo interstitial brachytherapy | Procedure or surgery | Treatment (interstitial brachytherapy) |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: From the first administration of study therapy up to 60 days
A 3+3 safety lead-in phase will be employed in order to determine the DLT for interstitial renal brachytherapy. Grading of DLTs will follow the guidelines provided in the Common Terminology Criteria for Adverse Events version 5.0 criteria.
One year (12-month) linear growth rate
Time frame: At 1 year
Adequate local control will be defined as minimal growth kinetics (=< 1 mm/year) on 1 year follow-up.
Results and safety
The study was stopped early (reason given: slow Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert J Chang principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Interstitial Radiation Therapy in people with Stage I Renal Cell Cancer and Stage II Renal Cell Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: From the first administration of study therapy up to 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.