Proton Therapy for Liver Metastases
Recruiting in Palo Alto (17 mi)
Overseen byGary Yang, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Loma Linda University
Disqualifiers: CNS metastases, Active liver infection, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Local control of hepatic metastases appears to be a major determinant of overall survival. However, many patients are not suitable for resection due to medical or surgical reasons. Therefore, there is an important role for a treatment that can provide the equivalent of tumor resection with minimal morbidity. Stereotactic body radiotherapy (SBRT) delivers an ablative regimen of highly focused external beam radiotherapy that targets one or more discrete extracranial lesions. Published reports using SBRT to treat liver metastases have shown actuarial local control rates ranging from 50-100% with higher doses associated with better local control.
In patients with metastatic liver disease, aggressive local therapy using modern radiotherapy techniques are promising and project to have a substantial role in the treatment of metastatic liver cancer to treat unresectable disease. The dosimetric advantage of proton therapy may lead to improved clinical outcomes with less morbidity, however, there is no clinical data to confirm this assertion. We thus propose a phase I study to determine the feasibility and safety of stereotactic body proton therapy in patients with liver metastases followed by a phase II study to determine the efficacy of such treatment on local control.
Will I have to stop taking my current medications?
The trial requires that any chemotherapy or targeted therapy be stopped at least 2 weeks before starting radiation and not resumed until at least 14 days after completing the proton therapy. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What data supports the effectiveness of the treatment Proton Therapy for Liver Metastases?
Proton therapy has been shown to deliver less radiation to nearby healthy organs compared to traditional X-ray therapy, which is important for liver cancers to reduce the risk of liver damage. Studies have shown that high-dose proton therapy can effectively control tumors with minimal side effects in liver cancer patients, including those with liver metastases.
12345Is proton therapy safe for treating liver metastases?
Proton therapy has been studied for safety in treating various cancers, including liver tumors and hepatocellular carcinoma (a type of liver cancer). Research suggests it can reduce damage to healthy tissues, which may lower the risk of side effects compared to traditional radiation therapy.
46789How is proton therapy different from other treatments for liver metastases?
Proton therapy is unique because it delivers radiation with a near-zero exit dose, meaning it spares more of the healthy liver tissue compared to traditional X-ray therapy. This can reduce the risk of radiation-induced liver disease and improve outcomes for patients with liver metastases.
1231011Eligibility Criteria
Adults with liver metastases from non-lymphoma cancers, who have good liver, kidney, and bone marrow function. They should not have had prior radiation that overlaps with the treatment area or active infections in the liver. Participants must be able to practice contraception and sign informed consent.Inclusion Criteria
I am fully active or can carry out light work.
My blood tests show I have enough white blood cells, platelets, and hemoglobin.
My kidney function is good (creatinine level is below 2mg/dL).
+12 more
Exclusion Criteria
I have had radiation therapy to my liver before.
Severe, active co-morbidity that may impact survival
I need frequent procedures to remove fluid from my abdomen.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Phase I Treatment
Determine the feasibility and safety of stereotactic body proton therapy in patients with liver metastases
6-8 weeks
Phase II Treatment
Determine the efficacy of stereotactic body proton therapy on local control of liver metastases
8-12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Participant Groups
The trial is testing stereotactic body proton therapy for patients with up to three liver lesions smaller than 5cm each. It's a two-phase study: Phase I checks if it's safe and doable; Phase II tests how well it controls cancer spread in the liver.
1Treatment groups
Experimental Treatment
Group I: Proton RadiationExperimental Treatment2 Interventions
Proton is already approved in United States, European Union, Japan for the following indications:
🇺🇸 Approved in United States as Proton Therapy for:
- Liver metastases
- Hepatocellular carcinoma
- Cholangiocarcinoma
🇪🇺 Approved in European Union as Proton Therapy for:
- Liver metastases
- Hepatocellular carcinoma
- Cholangiocarcinoma
🇯🇵 Approved in Japan as Proton Therapy for:
- Liver metastases
- Hepatocellular carcinoma
- Cholangiocarcinoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Loma Linda University Medical CenterLoma Linda, CA
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Who Is Running the Clinical Trial?
Loma Linda UniversityLead Sponsor
References
Clinical results of active scanning proton therapy for primary liver tumors. [2022]Evidence for the efficacy of radiation therapy for primary liver cancer is growing. In this context, proton therapy (PT) can potentially improve the therapeutic ratio, as demonstrated by recent clinical studies. Here we report the first European clinical experience on the use of PT for primary liver cancer.
Proton beam therapy for liver cancers. [2020]Proton beam therapy (PBT) delivers less dose to nearby normal organs compared to X-ray therapy (XRT), which is particularly relevant for treating liver cancers given that both mean and low liver dose are among the most significant predictors of radiation induced liver disease (RILD). High-dose PBT has been shown to achieve excellent long-term tumor control with minimal toxicity in hepatocellular carcinoma (HCC) patients. Increasing data support ablative PBT for patients with unresectable cholangiocarcinoma or liver metastases, especially those with larger tumors not suitable for XRT.
Dose-volume histogram analysis of the safety of proton beam therapy for unresectable hepatocellular carcinoma. [2018]To evaluate the safety and efficacy of radiotherapy using proton beam (PRT) for unresectable hepatocellular carcinoma.
Phase II study of radiotherapy employing proton beam for hepatocellular carcinoma. [2022]To evaluate the safety and efficacy of proton beam radiotherapy (PRT) for hepatocellular carcinoma.
The safety and efficacy of high-dose proton beam radiotherapy for hepatocellular carcinoma: a phase 2 prospective trial. [2022]Proton beam therapy (PBT) may provide useful local-regional treatment for hepatocellular carcinoma (HCC). The purpose of this study was to evaluate the safety and efficacy of PBT for HCC.
Proton Beam Therapy for Hepatocellular Carcinoma: Multicenter Prospective Registry Study in Japan. [2023]A prospective multicenter registry study was started May 2016 in Japan to evaluate the efficacy and safety of proton beam therapy (PBT) for hepatocellular carcinoma (HCC).
Proton Beam Therapy for Cancer in Children and Adults: A Health Technology Assessment. [2022]Proton beam therapy has potential to reduce late toxicity in cancer treatment by reducing the risk of damage to surrounding healthy tissues. We conducted a health technology assessment of proton beam therapy, compared with photon therapy, for children and adults with cancer requiring radiotherapy. Our assessment included an evaluation of safety, effectiveness, cost-effectiveness, the budget impact of publicly funding the construction and use of proton beam therapy in Ontario, and patient preferences and values.
Proton beam therapy for metastatic liver tumors. [2018]The purpose of this study was to investigate the safety and efficacy of proton beam therapy (PBT) for the treatment of metastatic liver tumors.
Early toxicity and patient reported quality-of-life in patients receiving proton therapy for localized prostate cancer: a single institutional review of prospectively recorded outcomes. [2019]We report prospectively captured clinical toxicity and patient reported outcomes in a single institutional cohort of patients treated for prostate cancer with proton beam therapy (PBT). This is the largest reported series of patients treated mostly with pencil beam scanning PBT.
Clinical Effectiveness of Hypofractionated Proton Beam Therapy for Liver Metastasis From Breast Cancer. [2022]Few studies of proton beam therapy (PBT) for patients with liver metastasis from breast cancer (LMBC) are available to date. The aim of the present study was to evaluate the clinical effectiveness of PBT for patients with LMBC.
Proton Therapy in the Management of Hepatocellular Carcinoma. [2022]Proton radiation therapy plays a central role in the treatment of hepatocellular carcinoma (HCC). Because of the near-zero exit dose and improved sparing of normal liver parenchyma, protons are being used even in challenging scenarios, including larger or multifocal liver tumors, and those associated with vascular tumor thrombus. There is a mounting level of evidence that suggests that protons are superior to photons in terms of survival and toxicity outcomes, specifically the progression to liver failure. A randomized controlled trial comparing protons to photons is currently underway to verify this hypothesis.