High Dose-Rate Brachytherapy for Liver Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Infectious disease, Heart failure, Pregnancy, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment High Dose-Rate Brachytherapy for liver cancer?
Research shows that high-dose-rate brachytherapy, when guided by computed tomography (CT), is effective in treating inoperable liver cancers by delivering targeted radiation. Studies have demonstrated its safety and ability to manage liver tumors, improving outcomes for patients who cannot undergo surgery.
12345Is high dose-rate brachytherapy generally safe for humans?
Research on high dose-rate brachytherapy, particularly in prostate cancer, suggests it is generally safe, with studies reporting on its safety and quality in treatment. While these studies focus on prostate cancer, they provide some reassurance about the treatment's safety in humans.
15678How is High Dose-Rate Brachytherapy different from other treatments for liver cancer?
High Dose-Rate Brachytherapy (HDR Brachytherapy) is unique because it delivers a high dose of radiation directly to the liver tumor through a minimally invasive procedure, allowing for precise targeting and minimizing damage to surrounding healthy tissue. This approach is particularly beneficial for inoperable liver cancers, offering a treatment option where surgery is not possible.
12359Eligibility Criteria
This trial is for adults over 18 with liver lesions larger than 3 cm, near large blood vessels or sensitive areas like the bowel. It's also for those with up to five unresectable tumors that are hard to treat due to poor blood vessel access or have a high risk of affecting other organs. People can't join if they're pregnant, have serious illnesses like heart failure, active infections, severe liver disease (Child-Pugh class C), very high bilirubin levels in their blood, low platelets count, or an INR > 1.5.Inclusion Criteria
I have up to five tumors that cannot be surgically removed.
- At least 3 cm (largest diameter in the axial plane)
My condition involves areas near important internal organs.
+5 more
Exclusion Criteria
Total serum bilirubin > 2 mg/dl
Platelet count < 50,000/ul
I have cancer that has spread widely, but I need treatment for symptoms caused by a specific tumor.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive high dose rate brachytherapy (HDRBT) for the treatment of unresectable liver malignancies
6 months
Multiple visits as per institutional standard of care
Follow-up
Participants are monitored for local tumor control (LTC) rates and overall survival (OS) at 3-month intervals
12 months
Regular follow-up visits every 3 months
Participant Groups
The study tests high-dose rate brachytherapy (HDRBT) using an iridium-192 isotope on primary and secondary liver malignancies which are not suitable for thermal ablation therapies. HDRBT aims to precisely target tumor cells without damaging nearby structures and can treat larger tumors effectively.
2Treatment groups
Experimental Treatment
Group I: Group B( Retrospective chart review )Experimental Treatment1 Intervention
40 patients who meet same eligibility criteria, but did not receive HDRBT between 1/1/2000 and 1/1/2021.
Group II: Group A (Prospective cohort )Experimental Treatment1 Intervention
20 patients, will undergo initial diagnostic workup, staging and treatment per institutional standard of care. Intervention: High dose rate brachytherapy (HDRBT)
High Dose-Rate Brachytherapy is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as HDR Brachytherapy for:
- Primary liver malignancies
- Secondary liver malignancies
- Hepatocellular carcinoma (HCC)
- Cholangiocarcinoma
- Liver metastases from colorectal cancer
- Pancreatic cancer
- Melanoma
- Breast cancer
- Lymph node metastases
🇺🇸 Approved in United States as HDR Brachytherapy for:
- Primary liver malignancies
- Secondary liver malignancies
- Hepatocellular carcinoma (HCC)
- Cholangiocarcinoma
- Liver metastases from colorectal cancer
- Pancreatic cancer
- Melanoma
- Breast cancer
- Lymph node metastases
🇨🇦 Approved in Canada as HDR Brachytherapy for:
- Primary liver malignancies
- Secondary liver malignancies
- Hepatocellular carcinoma (HCC)
- Cholangiocarcinoma
- Liver metastases from colorectal cancer
- Pancreatic cancer
- Melanoma
- Breast cancer
- Lymph node metastases
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
References
Patient-reported outcomes and health-related quality of life in prostate cancer treated with a single fraction of high dose rate brachytherapy combined with hypofractionated external beam radiotherapy. [2022]High dose rate (HDR) brachytherapy offers a highly conformal approach to radiotherapy delivery, enabling dose escalation. We report our experience using a combined HDR boost and external beam radiotherapy (EBRT) approach and its associated toxicity and effect on quality of life.
Hypofractionated accelerated computed tomography-guided interstitial high-dose-rate brachytherapy for liver malignancies. [2018]To report our results of computed tomography (CT)-guided interstitial high-dose-rate (HDR) brachytherapy (BRT) in the local treatment of inoperable primary and secondary liver malignancies.
High-dose-rate interstitial brachytherapy for liver metastases: first study from India. [2022]To study the safety and efficacy of high-dose-rate interstitial brachytherapy (HDRIBT) in patients with liver metastases (LM).
Computed tomography-guided interstitial high dose rate brachytherapy for centrally located liver tumours: a single institution study. [2022]To evaluate the clinical outcome of computed tomography (CT)-guided interstitial (IRT) high-dose-rate (HDR) brachytherapy (BRT) in the treatment of unresectable primary and secondary liver malignancies. This report updates and expands our previously described experience with this treatment technique.
A phase IB clinical trial of 15 Gy HDR brachytherapy followed by hypofractionated/SBRT in the management of intermediate-risk prostate cancer. [2023]High dose-rate (HDR) brachytherapy is commonly administered as a boost to external beam radiation therapy (EBRT). Our purpose was to compare toxicity with increasingly hypofractionated EBRT in combination with a single 15 Gy HDR boost for men with intermediate-risk prostate cancer.
Is single fraction 15 Gy the preferred high dose-rate brachytherapy boost dose for prostate cancer? [2022]High dose-rate (HDR) brachytherapy is most commonly administered as a boost in two or more fractions combined with external beam radiotherapy (EBRT). Our purpose is to compare outcomes with a single fraction HDR boost to that with a standard fractionated boost in intermediate risk prostate cancer.
Building a High-Dose-Rate Prostate Brachytherapy Program With Real-Time Ultrasound-Based Planning: Initial Safety, Quality, and Outcome Results. [2022]Growing evidence supports the efficacy and safety of high-dose-rate (HDR) brachytherapy as a boost or monotherapy in prostate cancer treatment. We initiated a new HDR prostate brachytherapy practice in April 2014. Here, we report the learning experiences, short-term safety, quality, and outcome.
Selection criteria for high-dose-rate surface brachytherapy and electron beam therapy in cutaneous oncology. [2022]High-dose-rate (HDR) brachytherapy is an alternative treatment to electron external beam radiation therapy (EBRT) of superficial skin lesions. The purpose of this study was to establish the selection criteria for HDR brachytherapy technique (HDR-BT) and EBRT in cutaneous oncology for various clinical scenarios.
Embedding expertise knowledge into inverse treatment planning for low-dose-rate brachytherapy of hepatic malignancies. [2023]Leveraging the precision of its radiation dose distribution and the minimization of postoperative complications, low-dose-rate (LDR) permanent seed brachytherapy is progressively adopted in addressing hepatic malignancies.