Proton Radiotherapy for Liver Cancer

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Severe illness, Uncontrolled illness, Lupus, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how proton radiotherapy, which uses high-energy beams, can treat liver cancer. It aims to determine the method's effectiveness for patients with hepatocellular carcinoma, a common type of liver cancer. The trial involves a specific radiation therapy plan conducted over several sessions. It suits patients with up to three liver lesions that can be targeted and who have undergone liver cancer treatments like surgery or chemoembolization at least six weeks prior. Participants should be able to return for follow-ups and have a manageable liver cancer status without significant spread outside the liver.

As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering a chance to contribute to important advancements in liver cancer treatment.

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 study team or your doctor.

What prior data suggests that proton stereotactic body radiation therapy is safe for treating liver cancer?

Research has shown that proton stereotactic body radiation therapy (SBRT) is generally safe for treating liver cancer. Studies indicate it can effectively target liver tumors without causing serious side effects. For example, one study on metastatic liver tumors found that SBRT controlled the tumors well. Another study examined six years of SBRT use in liver cancer patients and confirmed its safety and effectiveness.

When comparing SBRT with proton beam therapy, both treatments proved safe and effective for liver cancer that cannot be surgically removed. Patients tolerated the treatments well, with no major negative effects reported. Overall, research suggests that proton SBRT is a well-tolerated treatment option for liver cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Proton Stereotactic Body Radiation Therapy (SBPT) is unique because it uses protons instead of traditional X-rays to target liver cancer. This technique allows for more precise targeting of the tumor, minimizing damage to surrounding healthy tissues. As a result, patients might experience fewer side effects compared to conventional radiation therapies. Researchers are excited because this precision could mean higher doses to the tumor with potentially better outcomes and improved quality of life for patients.

What evidence suggests that proton radiotherapy might be an effective treatment for liver cancer?

Research has shown that proton stereotactic body radiation therapy (SBRT) effectively treats liver cancer. Studies have found that proton therapy successfully controls the cancer, with 90% of cases showing no regrowth in the treated area within three years. Additionally, SBRT has a 5-year success rate of 95% for primary liver cancer, which is very promising. The treatment is also considered safe, with no severe side effects reported in these studies. Overall, the evidence supports the effectiveness of proton SBRT in managing liver cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Jonathan B Ashman, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Adults with newly diagnosed or recurrent liver cancer, specifically hepatocellular carcinoma without metastases. They can have up to three treatable lesions and may have had prior local treatments. Participants should be in relatively good health (ECOG 0-2), with a life expectancy of at least 3 months, adequate blood counts, and no severe illnesses that could interfere with the study.

Inclusion Criteria

Absolute neutrophil count (ANC) >= 1000 cells/mm^3 (within 45 days of study entry)

My breast cancer is at an early or localized stage.

Able to and provides Institutional Review Board (IRB) approved study specific written informed consent

Exclusion Criteria

I am a woman who can have children and do not use birth control.

I cannot receive radiotherapy due to health reasons.

My liver has more than 3 highly likely cancerous lesions or too much disease for safe treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 1 SBPT fraction over 20-30 minutes per day for a total of 5 fractions

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Visits at 2 weeks, 3, 6, 12, and 24 months, then annually for 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Proton Stereotactic Body Radiation Therapy

Trial Overview The trial is testing stereotactic body proton radiotherapy for liver cancer treatment. This non-invasive method uses precise high-energy proton beams aimed at tumors to minimize damage to surrounding healthy tissue. The study will assess its effectiveness and impact on patients' quality of life.

How Is the Trial Designed?

Group I: Treatment (SBPT) Experimental Treatment 2 Interventions

Patients undergo 1 SBPT fraction over 20-30 minutes per day for a total of 5 fractions.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Proton stereotactic body radiation therapy (SBRT) demonstrated a high local control rate of 92.5% for liver metastases in a study of 46 patients, with a median follow-up of 15 months.

The treatment was well-tolerated, with low toxicity rates (37% grade 1 and 6.5% grade 2), and no severe toxicities or cases of radiation-induced liver disease, indicating a safe profile for managing multiple liver lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton stereotactic body radiation therapy for liver metastases-results of 5-year experience for 81 hepatic lesions. Coffman, AR., Sufficool, DC., Kang, JI., et al.[2022]

Proton beam radiotherapy (PRT) demonstrated excellent control of hepatocellular carcinoma (HCC) with a 2-year local progression-free rate of 96% among 30 patients, indicating its efficacy as a treatment option.

The treatment was well tolerated with minimal acute toxicity, and despite some patients experiencing hepatic insufficiency, PRT was completed as planned, suggesting it is a safe intervention for patients with liver cirrhosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of radiotherapy employing proton beam for hepatocellular carcinoma. Kawashima, M., Furuse, J., Nishio, T., et al.[2022]

In a study of 60 patients with unresectable hepatocellular carcinoma treated with proton beam radiotherapy, the 3-year local progression-free survival rate was 90%, indicating high efficacy of this treatment.

The study identified indocyanine-green retention rate (ICG R15) and the volume of noncancerous liver receiving radiation (V30) as important predictors for the risk of developing proton-induced hepatic insufficiency, helping to guide treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-volume histogram analysis of the safety of proton beam therapy for unresectable hepatocellular carcinoma. Kawashima, M., Kohno, R., Nakachi, K., et al.[2018]

In a study of 133 patients with unresectable hepatocellular carcinoma (HCC), proton radiation therapy significantly improved overall survival compared to photon therapy, with median survival times of 31 months for protons versus 14 months for photons.

Proton therapy also reduced the risk of non-classic radiation-induced liver disease, which is linked to worse survival outcomes, suggesting that proton therapy may help prevent liver decompensation after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protons versus Photons for Unresectable Hepatocellular Carcinoma: Liver Decompensation and Overall Survival. Sanford, NN., Pursley, J., Noe, B., et al.[2020]

Proton beam therapy (PBT) for hepatocellular carcinoma (HCC) demonstrated a median overall survival of 48.8 months and a 3-year local control rate of 90%, indicating its efficacy in treating this type of cancer.

The treatment had a low incidence of severe late adverse events, with only 4.7% of patients experiencing grade 3 or higher complications, suggesting that PBT is a safe option for patients with HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Beam Therapy for Hepatocellular Carcinoma: Multicenter Prospective Registry Study in Japan. Mizumoto, M., Ogino, H., Okumura, T., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6776803/

Proton beam therapy versus stereotactic body radiotherapy for ... Stereotactic body radiation therapy (SBRT) and proton beam therapy (PBT) generally are safe and effective for non-operative hepatocellular carcinoma (HCC).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10681147/

Proton liver stereotactic body radiation therapy: Treatment ... The study demonstrated that proton therapy with motion management techniques and robust optimization achieves excellent target coverage with low normal liver ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405630824001551

Long-term outcomes of more than a decade treating ... SBRT resulted in a 5-year LC of 95% in the treatment of primary liver cancer (HCC). •. No SBRT related ≥ grade 3 toxicity was reported. •. Treatment outcomes of ...

4. redjournal.org redjournal.org/article/S0360-3016(23)07969-5/fulltext

Proton Beam Therapy for Hepatocellular Carcinoma This multicenter prospective data registry indicated that PBT for HCC gives good therapeutic effects (3-year local control rate of 90%) with a ...

5. jgo.amegroups.org jgo.amegroups.org/article/view/49396/html

Proton stereotactic body radiation therapy for liver metastases ... SBRT has been shown to be safe in dose escalation studies (15-18) with excellent control rates above 90% with biologically effective doses (BED) >100 Gy10 (19).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8421917/

Proton stereotactic body radiation therapy for liver ... Proton SBRT for the treatment of liver metastases has promising LC rates with the ability to safely treat multiple liver metastases.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405630824001691

Stereotactic body radiation therapy in primary liver tumor To assess its efficacy and safety, we reviewed all patients treated by SBRT for a hepatocellular carcinoma (HCC) over a six-year period.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04805788

Stereotactic Body Proton Radiotherapy for the Treatment of ... This phase II trial studies the effect of stereotactic body proton radiotherapy in treating patients with liver cancer. Proton radiotherapy is a type of ...

9. jhep-reports.eu jhep-reports.eu/article/S2589-5559(22)00070-2/fulltext

Stereotactic body radiation therapy for hepatocellular ... The recent prospective and retrospective studies have shown the safety and efficacy of SBRT with 2-year local control ranging from 68-95%. •.