Proton Radiotherapy for Liver Cancer

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

9 Participants Needed

Trial Summary

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 data supports the effectiveness of Proton Stereotactic Body Radiation Therapy for liver cancer?

Research suggests that proton therapy, including stereotactic body proton radiotherapy, can be effective for liver cancer by targeting tumors precisely and sparing healthy tissue. Studies have shown it to be safe and potentially beneficial for patients with liver cancer, although there are challenges in its implementation. ^{1 2 3 4 5}

Is proton radiotherapy safe for liver cancer?

Research shows that proton radiotherapy, also known as proton beam therapy, has been studied for liver cancer and is generally considered safe for humans. Multiple studies have evaluated its safety, particularly for liver cancer, and have not reported significant safety concerns. ^{2 3 6 7 8}

How is Proton Stereotactic Body Radiation Therapy different from other treatments for liver cancer?

Proton Stereotactic Body Radiation Therapy (SBRT) for liver cancer is unique because it uses proton beams, which can deliver high doses of radiation directly to the tumor while minimizing damage to surrounding healthy tissues. This is particularly beneficial for liver cancer, as it helps protect the liver and other nearby organs from unnecessary radiation exposure. ^{2 3 4 9 10}

What is the purpose of this trial?

This phase II trial studies the effect of stereotactic body proton radiotherapy in treating patients with liver cancer. Proton radiotherapy is a type of treatment that uses high-energy beams to treat tumors.

Research Team

Jonathan B Ashman, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Potential Role of Intensity-Modulated Proton Therapy in Hepatic Carcinoma in Mitigating the Risk of Dose De-Escalation. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Dose-volume histogram analysis of the safety of proton beam therapy for unresectable hepatocellular carcinoma. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Phase II study of radiotherapy employing proton beam for hepatocellular carcinoma. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Challenges and opportunities in stereotactic body proton radiotherapy of liver malignancies. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Protons versus Photons for Unresectable Hepatocellular Carcinoma: Liver Decompensation and Overall Survival. [2020]

6. England pubmed.ncbi.nlm.nih.gov

What is the appropriate size criterion for proton radiotherapy for hepatocellular carcinoma? A dosimetric comparison of spot-scanning proton therapy versus intensity-modulated radiation therapy. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Proton Beam Therapy for Hepatocellular Carcinoma: Multicenter Prospective Registry Study in Japan. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Proton beam therapy for hepatocellular carcinoma located adjacent to the alimentary tract. [2018]

9. China pubmed.ncbi.nlm.nih.gov

Proton stereotactic body radiation therapy for liver metastases-results of 5-year experience for 81 hepatic lesions. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Stereotactic body proton therapy for liver tumors: Dosimetric advantages and their radiobiological and clinical implications. [2022]