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

Launched by M.D. ANDERSON CANCER CENTER · Sep 13, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called high-dose-rate brachytherapy (HDRBT) for patients with certain types of liver tumors, including primary liver cancers and cancers that have spread to the liver from other parts of the body. HDRBT uses a small radioactive source to deliver targeted radiation directly to the tumor, which can effectively treat larger tumors and those located near sensitive structures, without causing as much damage to surrounding healthy tissue. This treatment could be a valuable option for patients who cannot undergo traditional thermal therapies.

To be eligible for this trial, participants must be over 18 years old and have up to five tumors in the liver that are at least 3 cm in size and difficult to treat with other methods. Patients with certain health issues or severe liver problems may not be able to participate. Those who join the trial can expect to receive this innovative treatment, which may improve their quality of life and offer a new option when other treatments are not suitable. The trial is currently recruiting participants and aims to better understand how effective HDRBT is for a diverse group of patients.

Gender

ALL

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