High dose-rate brachytherapy for treating unresectable liver tumors
High Dose-Rate Brachytherapy for the Treatment of Both Primary and Secondary Unresectable Liver Malignancies
This study is testing a new way to treat liver tumors that can't be removed with surgery to see if it helps patients live longer and keep their tumors from growing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05053555 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with up to five unresectable liver tumors that meet specific size and proximity criteria.
Not a fit: Patients with active infectious diseases or uncontrolled intercurrent illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide improved local control of liver tumors and enhance overall survival for patients with unresectable malignancies.
How similar studies have performed: Other studies have shown promise with brachytherapy approaches, but this specific application for unresectable liver tumors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.