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Recruiting

High Dose-Rate Brachytherapy for the Treatment of Both Primary and Secondary Unresectable Liver Malignancies

NCT05053555 · M.D. Anderson Cancer Center
In plain English

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About this study
Primary Objective -To prospectively evaluate the clinical effectiveness of the use of high dose rate brachytherapy (HDRBT) for the treatment of both primary and secondary unresectable liver malignancies assessed by comparing local tumor control (LTC) rates at 6 months with a historical cohort. Secondary Objectives * To compare local tumor control rates at 3-month intervals between cohorts for the duration of the study (3 months, 9 months, 12 months, etc.). * To compare overall survival (OS) and progression-free survival (PFS) between cohorts.
Eligibility criteria
Inclusion Criteria: * GROUP A: Patients with liver lesions must be over the age of 18 * GROUP A: Any patient with up to five unresectable tumors that are: * At least 3 cm (largest diameter in the axial plane) * In close proximity to large blood vessels * In close proximity to sensitive structures (bowel, stomach, diaphragm, liver capsule, liver hilum, bile ducts) * Associated with difficult endovascular access to one or more feeding arterial branches (hypovascular tumors) * Associated with a large shunt fraction to other vital organs * GROUP B: Historical patients who meet the above criteria for group A but did not receive HDRBT between 01/01/2000 and 1/01/2021 Exclusion criteria: * Active infectious disease * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients with polymetastatic disease with the exception of those patients who may benefit from therapy addressing local complications directly related to the target lesion diminishing quality of life such as pain, vascular/biliary occlusion, and liver disfunction * Pregnancy (sexually active patients must be on birth control while participating in this study) * Child-Pugh class C * Total serum bilirubin \> 2 mg/dl * Platelet count \< 50,000/ul * International normalized ratio (INR) \> 1.5
Study design
Enrollment target: 60 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-04-24
Estimated completion: 2027-01-31
Last updated: 2026-05-22
Interventions
Device: high dose rate brachytherapyDevice: high dose rate brachytherapy
Primary outcomes
  • To prospectively evaluate the clinical effectiveness of the use of high dose rate brachytherapy (HDRBT) for the treatment of both primary liver malignancies. (Through study completion, an average of 1 year)
Sponsor
M.D. Anderson Cancer Center · other
Contacts & investigators
ContactJoshua Kuban · contact · jdkuban@mdanderson.org · 713-745-0944
InvestigatorJoshua Kuban · principal_investigator, M.D. Anderson Cancer Center
All locations (1)
M D Anderson Cancer CenterRecruiting
Houston, Texas, United States
High Dose-Rate Brachytherapy for the Treatment of Both Primary and Secondary Unresectable Liver Malignancies · TrialPath