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2022-04-24
2027-01-31
2027-01-31
60
NCT05053555
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
INTERVENTIONAL
High Dose-Rate Brachytherapy for the Treatment of Both Primary and Secondary Unresectable Liver Malignancies
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 utilized near sensitive structures such as the diaphragm, stomach, or bowel, and if performed near thermosensitive bile ducts, can result in cholestasis . Noting these limitations, percutaneous high-dose-rate brachytherapy was brought into clinical practice by Ricke et al. in Europe in 2002 . This therapy utilizes an iridium-192 (192Ir) isotope to administer a cytotoxic dose of radiation to a target lesion. It is not susceptible to heat sink effects and can also deliver radiation with the precision necessary to cause tumor death without destroying the integrity of neighboring structures. Additionally, it can be used to treat larger tumors (>3cm) as it is not associated the same size limitations as ablative techniques and can also be utilized to treat lesions that are not amenable to intra-arterial therapies (such as trans-arterial chemoembolization and yttrium-90 radioembolization). Since its inception, HDRBT has been evaluated through multiple studies investigating its use to treat lesions throughout the body including both primary and secondary liver malignancies such as hepatocellular carcinoma (HCC), cholangiocarcinoma, metastasis to the liver from colorectal cancer, pancreatic cancer , melanoma , and breast cancer . Its use in treating lymph node metastases has also been investigated . These studies have demonstrated the feasibility, safety, and clinical effectiveness of this method, establishing it as a therapeutic option when use of thermal ablation therapies is restricted. Most studies however, have been retrospective and have been performed outside the United States. Studying this therapy will add a crucial treatment option to our current armamentarium, filling a gap in currently available therapies and additionally allowing for further investigation of the use of HDRBT in a larger and more diverse population.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-08-24 | N/A | 2025-06-02 |
2021-09-13 | N/A | 2025-06-04 |
2021-09-22 | N/A | 2025-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Group A (Prospective cohort ) 20 patients, will undergo initial diagnostic workup, staging and treatment per institutional standard of care. Intervention: High dose rate brachytherapy (HDRBT) | DEVICE: high dose rate brachytherapy
|
| EXPERIMENTAL: Group B( Retrospective chart review ) 40 patients who meet same eligibility criteria, but did not receive HDRBT between 1/1/2000 and 1/1/2021. | DEVICE: high dose rate brachytherapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Joshua Kuban Phone Number: 713-745-0944 Email: jdkuban@mdanderson.org |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
