- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04473781
Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer
Prospective Study of Interstitial Brachytherapy for Unresectable/Unablatable T1b/T2a Renal Masses
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. 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:
I. 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 Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- UCLA / Jonsson Comprehensive Cancer Center
-
Contact:
- Bashir Wyatt
- Phone Number: 310-794-3448
- Email: BAWyatt@mednet.ucla.edu
-
Principal Investigator:
- Albert J. Chang
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (interstitial brachytherapy)
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.
|
Undergo interstitial brachytherapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From the first administration of study therapy up to 60 days
|
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.
|
At 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Albert J Chang, UCLA / Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
Other Study ID Numbers
- 19-001258
- NCI-2020-04542 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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