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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I of study: Number of participants with adverse events as a measure of safety and tolerability

Secondary outcome measures

Phase II -local control within irradiated fields at 2 years

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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor

306 Previous Clinical Trials

260,953 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrolment capacity of this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical investigation is still recruiting participants. It was initially posted on August 22nd 2012 and updated as recently as February 16th 2022. The study requires 35 volunteer from a single site."

Answered by AI

Are there currently any open slots for participation in this experiment?

"Affirmative. Clinicaltrials.gov suggests that this medical trial, which was promulgated on August 22nd 2012, is currently recruiting participants. 35 patients need to be enrolled at 1 site for the study to go ahead as planned."

Answered by AI

Recent research and studies

Journal of Gastrointestinal OncologyJournal

A Phase I Trial of Proton Stereotactic Body Radiation Therapy for Liver Metastases

Kang, Joseph I., Daniel C. Sufficool, Chung-Tsen Hsueh, Andrew J. Wroe, Baldev Patyal, Mark E. Reeves, Jerry D. Slater, and Gary Y. Yang. 2018. “A Phase I Trial of Proton Stereotactic Body Radiation Therapy for Liver Metastases”. Journal of Gastrointestinal Oncology. AME Publishing Company. doi:10.21037/jgo.2018.08.17.

clinicaltrials.govStudy

Proton Therapy in the Treatment of Liver Metastases

Gary Yang, MD 2012. "Proton Therapy in the Treatment of Liver Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01697371.

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