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

RecruitingNAAges 19 Years - anyAllM.D. Anderson Cancer Center
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In plain words

What the trial is, and whether it could suit you

Over the past three decades, the treatment of both primary and secondary liver malignancies has been improved by the development and optimization of multiple minimally invasive thermal ablative therapies. These advances have resulted in a myriad of benefits for patients including decreased morbidity, mortality, as well as increased longevity and quality of life. However, these therapies can only be performed within certain parameters. Thermal ablative techniques such as radiofrequency ablation (RFA) and microwave ablation (MVA) are recommended for small lesions under 3 cm due to decreased efficacy when attempting to treat larger lesions. Additionally, large vessels in close proximity to a target lesion may result in heat dissipation, termed the "heat sink" effect, and result in incomplete ablation of the lesion. Furthermore, thermal ablative techniques cause off-target damage when utiliz

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • high dose rate brachytherapy
  • high dose rate brachytherapy
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Where

1 site
M D Anderson Cancer Center
Houston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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