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Liver-Directed Therapies vs. Radiation Therapy for Liver Cancer

N/A

Recruiting

Led By Manisha Palta, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HCC diagnosed either by histology/pathology or Liver Imaging Reporting and Data System (LIRADs 5 per the ACR's LIRADs criteria 10) by CT or MRI

Lesion amenable to treatment with both Interventional Radiology Liver Directed Therapies and HIGRT.

Must not have

Child Pugh score B9 or Class C

Fluctuating ascites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 3 months, 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two different cancer treatments to see which one results in a better quality of life for patients.

Who is the study for?

This trial is for adults with liver cancer (Hepatocellular Carcinoma) who are in relatively good health, have a specific score indicating their liver's condition (Child Pugh A5 to B8), and have up to 3 treatable lesions no larger than 5cm. It excludes those with more advanced liver issues, prior liver radiation unless approved by the lead researcher, current systemic cancer therapy, or unstable fluid accumulation in the abdomen.

What is being tested?

The study aims to assess changes in patients' quality of life after receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy. Quality of life will be measured using EORTC C-30 questionnaires before and one month after treatment.

What are the potential side effects?

While not explicitly listed here, side effects may include typical reactions associated with radiological treatments such as fatigue, nausea, abdominal pain, and potential impacts on liver function which will be monitored through the quality of life questionnaires.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver cancer diagnosis was confirmed by a biopsy or specific liver imaging.

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My liver lesion can be treated with targeted radiology and high-intensity radiation.

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My liver function score is within a mild to moderate range.

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I am able to get out of my bed or chair and move around.

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My cancer lesion is 5cm or smaller.

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I have 3 or fewer liver lesions to be treated.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver disease is severe.

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I experience changes in the amount of fluid in my abdomen.

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I am currently receiving treatment for liver cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy

Secondary study objectives

change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Interventional Radiology Liver Directed Therapies (ILDT)Active Control1 Intervention

ILDT includes ablations such as microwave ablation and percutaneous local ablation and embolotherapies including bland embolization, chemoembolization and radioembolization.

Group II: Hypofractionated Image-Guided Radiation Therapy (HIGRT)Active Control1 Intervention

HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,455 Previous Clinical Trials

2,971,474 Total Patients Enrolled

1 Trials studying Hepatocellular Carcinoma

12 Patients Enrolled for Hepatocellular Carcinoma

Manisha Palta, MDPrincipal InvestigatorDuke Health

7 Previous Clinical Trials

13,406 Total Patients Enrolled

1 Trials studying Hepatocellular Carcinoma

12 Patients Enrolled for Hepatocellular Carcinoma

Media Library

Interventional Radiology Liver Directed Therapies (ILDT) Clinical Trial Eligibility Overview. Trial Name: NCT04933435 — N/A

$Hepatocellular Carcinoma Research Study Groups: Interventional Radiology Liver Directed Therapies (ILDT), Hypofractionated Image-Guided Radiation Therapy (HIGRT)$