High dose-rate brachytherapy for treating unresectable liver tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of high dose-rate brachytherapy (HDRBT) in treating both primary and secondary unresectable liver malignancies. The study aims to compare local tumor control rates at 6 months with a historical cohort and assess overall survival and progression-free survival over time. Patients with specific criteria, including unresectable tumors larger than 3 cm and those near sensitive structures, will be included in the trial. The approach seeks to improve treatment outcomes for patients who are not candidates for traditional thermal ablative therapies.

Why it matters

Who can join: the full rules

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

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Joshua Kuban — M.D. Anderson Cancer Center
• Study coordinator: Joshua Kuban
• Email: jdkuban@mdanderson.org
• Phone: 713-745-0944

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.