RECRUITING

Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer

Talk to us

Conditions

Stage I Renal Cell CancerStage II Renal Cell Cancer

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Study of Interstitial Brachytherapy for Unresectable/Unablatable T1b/T2a Renal Masses

Quick Facts

Study Start:2020-07-16
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04473781

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Elected to undergo interstitial brachytherapy as part of conventional treatment for renal cell carcinoma
  2. * Biopsy proven renal cell carcinoma
  3. * No definitive evidence of locally advanced (nodal or tumor thrombus) or distant (metastatic) disease
  4. * Lesion size (maximal dimension) of 4 to 10 cm
  5. * Patient not a candidate for curative surgery (unwilling or unable to pursue surgery)
  6. * Lesion cannot be reliably treated with ablative techniques
  7. * Entire lesion able to be treated adequately by brachytherapy per radiation oncologist
  8. * Tumor predominantly solid (\~ \> 80%)
  9. * Lesion that has been observed for \>= 6 months with demonstrable growth rate anticipated to be \>= 4 mm/year by same imaging modality
  10. * Renal tumor that is amenable to percutaneous access for interstitial renal brachytherapy (Institutional Review Board \[IRB\])
  11. * Hemoglobin \> 9
  12. * Absolute neutrophil count (ANC) \>= 1500/uL (microliter)
  13. * Platelets \>= 100,000/uL
  14. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 upper limit of normal (ULN)
  15. * Total bilirubin =\< ULN
  16. * A competent immune system
  17. * Estimated glomerular filtration rate (eGFR) \>= 30
  18. * Good performance status (Eastern Cooperative Oncology Group \[ECOG\]) \< 2
  19. * Understanding and willingness to provide consent
  20. * No prior systemic treatment for kidney cancer
  21. * Women of childbearing potential must have negative pregnancy test at start of therapy
  1. * Presence of an active, untreated, non-renal malignancy
  2. * Uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction within 6 months
  3. * History of bleeding diathesis or recent bleeding episode
  4. * Need for urgent treatment of renal cancer due bleeding, pain, or paraneoplastic syndrome
  5. * Prior surgery or radiation therapy to the operative site
  6. * Unwillingness to undergo clinical and laboratory monitoring and/or imaging studies

Contacts and Locations

Principal Investigator

Albert J Chang
PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center

Study Locations (Sites)

UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: Jonsson Comprehensive Cancer Center

  • Albert J Chang, PRINCIPAL_INVESTIGATOR, UCLA / Jonsson Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-16
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2020-07-16
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Stage I Renal Cell Cancer
  • Stage II Renal Cell Cancer