NCT04473781

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 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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
14mo left

Started Jul 2020

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jul 2020Jun 2027

First Submitted

Initial submission to the registry

July 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 16, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 2, 2026

Status Verified

July 1, 2025

Enrollment Period

6 years

First QC Date

July 13, 2020

Last Update Submit

February 26, 2026

Conditions

Stage I Renal Cell CancerStage II Renal Cell Cancer

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    At 1 year

Study Arms (1)

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.

Procedure: Interstitial Radiation Therapy

Interventions

Interstitial Radiation TherapyPROCEDURE

Undergo interstitial brachytherapy

Also known as: BRACHYTHERAPY, INTERSTITIAL, Implant Radiation
Treatment (interstitial brachytherapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +6 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Albert J Chang

    UCLA / Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 16, 2020

Study Start

July 16, 2020

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

March 2, 2026

Record last verified: 2025-07

Locations

US(1)