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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.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

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

Secondary outcome measures

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

Acute Coryza

number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy

+2 more

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,360 Previous Clinical Trials

3,420,252 Total Patients Enrolled

4 Trials studying Liver Cancer

1,208 Patients Enrolled for Liver Cancer

Manisha Palta, MDPrincipal InvestigatorDuke Health

7 Previous Clinical Trials

13,406 Total Patients Enrolled

Media Library

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

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

Liver Cancer Clinical Trial 2023: Interventional Radiology Liver Directed Therapies (ILDT) Highlights & Side Effects. Trial Name: NCT04933435 — N/A

Interventional Radiology Liver Directed Therapies (ILDT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04933435 — N/A

Frequently Asked Questions

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

How many people have committed to taking part in this experiment?

"Affirmative, clinicaltrials.gov reveals that this clinical trial is currently accepting patients. Initially posted on November 12th 2020 and recently revised on August 10th 2022, the research requires 78 individuals from 2 sites to participate in the study."

Answered by AI

Is this experiment recruiting participants at the moment?

"This medical research is currently enrolling participants according to the clinicaltrials.gov database, which displays an initial posting date of November 12th 2020 and a recent update on August 10th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients

2020. "Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04933435.

All > Hcc > Hepatocellular Carcinoma