High Dose-Rate Brachytherapy for Liver Cancer

Overseen By Joshua Kuban

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Infectious disease, Heart failure, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called High Dose-Rate Brachytherapy for liver cancer. The goal is to evaluate how well this therapy works for liver tumors that are difficult to treat due to their size or proximity to important structures. This treatment uses radiation to target tumors precisely, minimizing damage to nearby organs and tissues. Eligible participants may have up to five liver tumors that cannot be surgically removed, particularly if the tumors exceed 3 cm or are near blood vessels or sensitive organs. As an unphased trial, this study provides a unique opportunity to access cutting-edge treatment options for challenging liver tumors.

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 prior data suggests that high dose-rate brachytherapy is safe for liver cancer?

Research has shown that High Dose-Rate Brachytherapy (HDRBT) is generally safe for treating liver cancer. Studies have found it to be a well-tolerated option with few complications. One study highlighted that CT-guided HDRBT effectively manages large or difficult liver cancer recurrences. Another study noted that HDRBT is a minimally invasive treatment with few side effects. This makes HDRBT a reliable choice for patients, especially when other treatments aren't suitable. Patients should always consult their healthcare provider to understand the potential risks and benefits for their specific situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

High Dose-Rate Brachytherapy (HDRBT) is unique because it delivers radiation directly to liver cancer tumors, minimizing exposure to healthy surrounding tissues. Unlike traditional external beam radiation, HDRBT provides a high dose of radiation in a very focused manner, which could potentially lead to fewer side effects and better protection of liver function. Researchers are excited because this precise targeting might offer improved outcomes and quality of life for patients compared to the standard treatments like surgery, chemotherapy, or traditional radiation therapy.

What evidence suggests that high dose-rate brachytherapy is effective for liver cancer?

Research has shown that high dose-rate brachytherapy (HDRBT) effectively treats liver cancer. Studies have found that HDRBT can safely target liver tumors larger than 3 cm, avoiding issues like the "heat sink" effect that can interfere with other treatments. One study discovered that HDRBT delivers twice the radiation dose to liver tumors, making it more effective than other methods. Additionally, HDRBT precisely protects nearby organs, reducing potential harm. In this trial, Group A will receive HDRBT, highlighting its promise as an option when other treatments have limitations. ^{1 2 3 6 7}

Who Is on the Research Team?

Joshua Kuban, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• High Dose-Rate Brachytherapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Group B( Retrospective chart review ) Experimental Treatment 1 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 Treatment 1 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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

CT-guided interstitial high-dose-rate brachytherapy (IRT HDR BRT) shows high local control rates for liver tumors, achieving 89% for metastatic tumors and 90% for primary tumors at 6 months, indicating its efficacy in treating unresectable liver malignancies.

The procedure is considered safe, with only 5% of interventions resulting in severe side effects and no treatment-related deaths reported, highlighting its potential as a viable option for patients with extensive liver tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed tomography-guided interstitial high dose rate brachytherapy for centrally located liver tumours: a single institution study. Tselis, N., Chatzikonstantinou, G., Kolotas, C., et al.[2022]

High-dose-rate (HDR) brachytherapy provides better coverage of clinical target volumes (CTVs) for complex and curved skin lesions compared to electron external beam radiation therapy (EBRT), especially when the lesions are large or have complicated shapes.

The study found that while both HDR-BT and EBRT can effectively treat superficial lesions, HDR-BT showed superior dose distribution, particularly in cases where the curvature of the treatment area increased, leading to a significant loss of coverage with EBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selection criteria for high-dose-rate surface brachytherapy and electron beam therapy in cutaneous oncology. Buzurovic, IM., O'Farrell, DA., Harris, TC., et al.[2022]

In a study of 95 patients with intermediate- or high-risk prostate cancer, a combined approach of high dose rate (HDR) brachytherapy and external beam radiotherapy (EBRT) was found to be well-tolerated, with manageable levels of toxicity reported by patients.

While urinary and bowel symptoms peaked shortly after treatment, most patients reported a return to baseline quality of life within 6 to 24 months, indicating that this treatment regimen effectively balances dose escalation with patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Choudhury, A., Arthur, C., Malik, J., et al.[2022]

The study developed a new treatment planning system (TPS) for low-dose-rate (LDR) permanent seed brachytherapy targeting liver tumors, which integrates advanced deep learning for multi-organ segmentation and improves planning efficiency.

Testing showed that the TPS outperformed commercial systems in terms of dose-volume-histogram criteria and execution time, indicating its potential for optimizing treatment while minimizing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embedding expertise knowledge into inverse treatment planning for low-dose-rate brachytherapy of hepatic malignancies. Zhu, J., Wang, C., Teng, S., et al.[2023]

CT-guided interstitial high-dose-rate brachytherapy (HDR-BRT) is a safe and effective treatment for inoperable liver tumors, with a 66% overall survival rate at one year and a low incidence of severe side effects (4.7%).

The local control rates for metastatic lesions were 79% at one year, while for primary hepatic tumors, the control rate was 88%, indicating that HDR-BRT can significantly manage tumor growth in challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated accelerated computed tomography-guided interstitial high-dose-rate brachytherapy for liver malignancies. Tselis, N., Chatzikonstantinou, G., Kolotas, C., et al.[2018]

High-dose-rate interstitial brachytherapy (HDRIBT) was found to be a safe treatment for liver metastases, with no fatal complications reported among the 10 patients studied, and only minor side effects observed.

The treatment demonstrated a 75% local control rate at 12 months, indicating its efficacy as a non-surgical option for patients who are ineligible for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate interstitial brachytherapy for liver metastases: first study from India. Sharma, DN., Thulkar, S., Sharma, S., et al.[2022]

In a clinical trial involving 42 men with intermediate-risk prostate cancer, a treatment combining a single 15 Gy HDR brachytherapy boost with a five-fraction external beam radiation therapy (EBRT) resulted in a high biochemical disease-free survival rate of 95.5% after a median follow-up of 36 months.

The treatment demonstrated low toxicity, with only one case of acute Grade 3 gastrointestinal and genitourinary toxicity, and no significant differences in health-related quality of life across urinary, bowel, or sexual domains, suggesting it is a safe and effective option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase IB clinical trial of 15 Gy HDR brachytherapy followed by hypofractionated/SBRT in the management of intermediate-risk prostate cancer. Den, RB., Greenspan, J., Doyle, LA., et al.[2023]

In a study of 164 men treated with high-dose-rate (HDR) brachytherapy for prostate cancer, the procedure showed a low incidence of genitourinary (GU) and gastrointestinal (GI) complications, indicating it is a safe treatment option.

With a median follow-up of 18.6 months, HDR brachytherapy resulted in a high overall survival rate of 98.7% and a disease-free survival rate of 96.2%, demonstrating its efficacy in treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a High-Dose-Rate Prostate Brachytherapy Program With Real-Time Ultrasound-Based Planning: Initial Safety, Quality, and Outcome Results. Zhang, H., Kang, S., Ali, N., et al.[2022]

The Single Fraction HDR brachytherapy protocol (15 Gy in one session) demonstrated a high biochemical disease-free survival rate of 95.1%, comparable to the Standard Fractionation protocol (97.9%) over a median follow-up of 45 months, indicating its efficacy in treating intermediate risk prostate cancer.

Both treatment protocols showed similar rates of late urinary and rectal toxicity, as well as health-related quality of life, suggesting that the Single Fraction approach is not only effective but also safe, potentially offering a more resource-efficient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is single fraction 15 Gy the preferred high dose-rate brachytherapy boost dose for prostate cancer? Morton, G., Loblaw, A., Cheung, P., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8920984/

Narrative Review of High-Dose-Rate Interstitial Brachytherapy ... This review article aims to describe the high-dose-rate liver brachytherapy technique, its selection criteria, present its advantages and disadvantages

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405631625001162

Comparison of interstitial high-dose-rate brachytherapy ... Average dose to the liver tumor was increased by a factor two with brachytherapy. •. Brachytherapy achieved optimal sparing of gastrointestinal organs. •.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0748798324004815

Effectiveness and safety of computed tomography-guided ... Purpose. To assess the efficacy and safety of computed tomography (CT)-guided high-dose-rate HDR) brachytherapy in treating recurrent hepatocellular carcinoma ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40727255/

Comparison of interstitial high-dose-rate brachytherapy ... We aimed to compare high-dose-rate interstitial brachytherapy (HDR-iBT) and stereotactic body radiotherapy (SBRT) in free breathing (FB) and ...

5. nature.com nature.com/articles/s41598-025-09227-0

Computed tomography guided high dose rate ... We report the largest cohort demonstrating CT-BRT as an effective local treatment for colorectal liver metastases in induced oligoprogression, with minimal ...

6. mdpi.com mdpi.com/2077-0383/13/24/7550

Interstitial High-Dose-Rate Brachytherapy Combined with ... The overall clinical response rate was 83.33% with five out of six patients achieving local control, while one out of six (16.66%) showed local and general ...

7. journals.lww.com journals.lww.com/cancerjournal/fulltext/2023/19002/percutaneous_high_dose_rate_interstitial.56.aspx

Percutaneous high-dose-rate interstitial brachytherapy for... Percutaneous CT-guided high-dose-rate interstitial brachytherapy is a minimally invasive, safe, and feasible treatment option with minimal complication.