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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

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 below

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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:

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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.

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I am not pregnant, nursing, or able to become pregnant and will use contraception.

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My cancer has spread near my digestive system.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

2009

N/A

~170

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor

312 Previous Clinical Trials

260,870 Total Patients Enrolled

Gary Yang, MDPrincipal Investigator - gyang@llu.edu

Loma Linda University

3 Previous Clinical Trials

54 Total Patients Enrolled

Media Library

Proton (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01697371 — N/A

Liver Metastases Research Study Groups: Proton Radiation

Liver Metastases Clinical Trial 2023: Proton Highlights & Side Effects. Trial Name: NCT01697371 — N/A

Proton (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01697371 — N/A

~9 spots leftby Sep 2028

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