An interventional study of Proton and Proton Radiation in Liver Metastases, sponsored by Loma Linda University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
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.
Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
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Pathologically confirmed non-lymphoma liver metastases or
New radiographic liver lesions consistent with metastases in patients with known pathologically confirmed non-lymphoma cancer
1-3 liver lesions measurable on CT/MRI or PET/CT performed within 6 weeks prior to study entry
Liver metastases measuring \<5cm
Life expectancy >6 months
Disease outside the liver is allowed
Age ≥ 18
ECOG Performance Scale = 0-1
Adequate bone marrow function, defined as follows:
Adequate kidney function (serum creatinine \<2mg/dL) based on chemistry panel obtained within 4 weeks prior to registration on study
Adequate liver function, defined as total bilirubin \<5 mg/dL, serum albumin >2.0g/dL, serum levels of liver enzymes \< 5 times the upper limit of normal, and INR \< 1.5
Previous liver resection or ablative therapy is permitted
Chemotherapy and/or targeted agent therapy must be completed at least 2 weeks prior to radiation and started at least 14 days after completion of SBPT Women of childbearing potential and male participants must practice adequate contraception
Patient must sign study specific informed consent prior to study entry
Pretreatment evaluations required for eligibility include:
Exclusion Criteria:
Prior invasive malignancy other than liver met primary (except non-melanomatous skin cancer) unless disease free for > 3years
Prior radiotherapy that would results in overlap of radiation fields
Prior radiotherapy to the liver
Severe, active co-morbidity that may impact survival
CNS metastases
Tense ascites requiring frequent paracentesis
Active liver infection
Pregnancy, nursing women, or women of child bearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Metastases location within 2cm of GI tract
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Radiation: Proton · Radiation: Proton Radiation
All patients will receive 3 fractions in no more than 14 days at the following levels: Level I = 12 Gy per fraction, total dose=36 Gy. Level II = 16 Gy per fraction, total dose 48 Gy. Level III = 20 Gy per fraction, total dose 60 Gy. The dose per fraction to the PTV will start at dose level I (12 Gy), but may vary from 12 Gy to 20 Gy in 3 fractions over 14 days in 4 Gy increments
Phase I of study: Number of participants with adverse events as a measure of safety and tolerability
Time frame: The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months
Phase II -local control within irradiated fields at 2 years
Time frame: The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months
Plan to share: No
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