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Proton Beam Therapy
Proton Therapy for Liver Metastases
N/A
Recruiting
Led By Gary Yang, MD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Scale = 0-1
Adequate bone marrow function: ANC ≥ 1,000 cells/mm3, Platelets ≥ 60,000 cell/mm3, Hemoglobin ≥ 8.0 g/dl
Must not have
Prior radiotherapy to the liver
Tense ascites requiring frequent paracentesis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a novel proton therapy approach to treating patients with metastatic liver cancer that is not able to be surgically removed. This is a Phase I/II study, which means they are testing to see if the treatment is safe (Phase I) and then if it is effective (Phase II).
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of proton therapy may include skin reactions at the treatment site, fatigue, nausea, changes in appetite, and potential damage to nearby organs or tissues due to radiation exposure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My blood tests show I have enough white blood cells, platelets, and hemoglobin.
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My kidney function is good (creatinine level is below 2mg/dL).
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My liver is functioning well according to recent tests.
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My liver cancer spread is less than 5cm in size.
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I am 18 years old or older.
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I've had a full check-up, blood tests, and a pregnancy test (if applicable) within the last month.
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My cancer has spread to my liver and it's not lymphoma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had radiation therapy to my liver before.
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I need frequent procedures to remove fluid from my abdomen.
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I have had radiotherapy in an area that cannot be treated again.
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I have an active liver infection.
Select...
I am not pregnant, nursing, or able to become pregnant and will use contraception.
Select...
My cancer has spread near my digestive system.
Select...
My cancer has spread to my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Proton RadiationExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton
2009
N/A
~170
Proton Radiation
2010
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
315 Previous Clinical Trials
266,555 Total Patients Enrolled
Gary Yang, MDPrincipal Investigator - gyang@llu.edu
Loma Linda University
3 Previous Clinical Trials
54 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy to my liver before.I need frequent procedures to remove fluid from my abdomen.I have been cancer-free for over 3 years, except for liver or non-melanoma skin cancer.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).My liver is functioning well according to recent tests.I have 1 to 3 liver lesions that can be seen on recent scans.My liver cancer spread is less than 5cm in size.My cancer has spread outside the liver.I am 18 years old or older.I have had surgery or treatment to remove or destroy liver tissue.I finished chemotherapy or targeted therapy 2 weeks before radiation and started it 14 days after SBPT.I have had radiotherapy in an area that cannot be treated again.I have an active liver infection.I am not pregnant, nursing, or able to become pregnant and will use contraception.My cancer has spread near my digestive system.My cancer has spread to my liver and it's not lymphoma.I've had a full check-up, blood tests, and a pregnancy test (if applicable) within the last month.I have signed the consent form for this study.My cancer has spread to my brain.
Research Study Groups:
This trial has the following groups:- Group 1: Proton Radiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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