Liver MetastasesNCT01697371
Proton Therapy in the Treatment of Liver Metastases
A study testing Proton and Proton Radiation in people with Liver Metastases, run by Loma Linda University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases
- What is being tested?
- Proton and Proton Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2012to Sep 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Age ≥ 18
- ECOG Performance Scale = 0-1
- Adequate bone marrow function, defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 based upon CBC/differential obtained within 4 weeks prior to registration on study
- Platelets ≥ 60,000 cell/mm3 based upon CBC/differential obtained within 4 weeks prior to registration on study
- Hemoglobin ≥ 8.0 g/dl based upon CBC/differential obtained within 4 weeks prior to registration on study (Note: the use of transfusion or other intervention to achieve Hgb ≥ 8.0 is acceptable.)
- 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:
- A complete history and general physical examination
- For women of childbearing potential, a serum or urine pregnancy test must be performed within 72 hours prior to registration
- INR, total bilirubin, albumin, alkaline phosphatase, ALT, AST within 4 weeks prior to study entry
Who cannot join
- 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
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- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Proton Referral Office First Call: Referral Office intake personnel contact
United States1 site, 1 recruiting
- Recruiting
Loma Linda University Medical Center
Loma Linda, California, 92354
Gary Yang, MD
About this study
Official title: Phase I-II Trial of Stereotactic Body Proton Therapy for Patients With Liver Metastases
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.
- Conditions
- Liver Metastases
- Being tested
- Proton, Proton Radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProtonRadiation
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
Proton RadiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Proton Radiation | Experimental | Not described Receives: Radiation: Proton; Radiation: Proton Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I of study: Number of participants with adverse events as a measure of safety and tolerability
Measured: 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
Secondary outcomes (1)
Phase II -local control within irradiated fields at 2 years
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study start22 Aug 2012
- Primary completionSep 2028 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Yang, MD, Principal investigator, gyang@llu.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697371
- Sponsor's protocol ID
- 5120022
- Status last verified
- Jun 2026
- First submitted
- 7 Sep 2012
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kang JI, Sufficool DC, Hsueh CT, Wroe AJ, Patyal B, Reeves ME, Slater JD, Yang GY. A phase I trial of Proton stereotactic body radiation therapy for liver metastases. J Gastrointest Oncol. 2019 Feb;10(1):112-117. doi: 10.21037/jgo.2018.08.17.
PubMed 30788166
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Trial of Stereotactic Body Proton Therapy for Patients With Liver Metastases
- ClinicalTrials.gov ID
- NCT01697371
- Acronym / sponsor ID
- 5120022
- Conditions
- Liver Metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 22 Aug 2012 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Radiation | Experimental | Radiation: Proton, Radiation: Proton Radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProtonAll 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 | Radiation | Proton Radiation |
| Proton Radiation | Radiation | Proton Radiation |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Results publication: PubMed 30788166Kang JI, Sufficool DC, Hsueh CT, Wroe AJ, Patyal B, Reeves ME, Slater JD, Yang GY. A phase I trial of Proton stereotactic body radiation therapy for liver metastases. J Gastrointest Oncol. 2019 Feb;10(1):112-117. doi: 10.21037/jgo.2018.08.17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Proton Referral Office First Call: Referral Office intake personnel contact
Gary Yang, MD principal investigator
gyang@llu.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton and Proton Radiation in people with Liver Metastases, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Proton Referral Office First Call: Referral Office intake personnel (909-558-4288 or 1 800 PROTONS), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01697371, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.