PROVE-HCC: A study for People with Liver Cancer

Purpose of this Study

We are doing this study to measure quality of life and compare signs such as tiredness, feeling of unease, discomfort in the stomach, and pain in patients who have been treated with either PLA or HIGRT for liver cancer.

Who Can Participate?

Eligibility

Adults who:<ul>
<li>Are diagnosed with 1-3 liver tumors that are less than or equal to 5cm in size</li>
<li>Can be treated with either PLA or HIGRT</li></ul>

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

If you choose to join this study, you will get a random assignment (like drawing numbers from a hat) assigned to one of the following standard of care treatments:<ul>
<li>Percutaneous Local Ablation (PLA) - This treatment involves inserting special needles into the liver and using microwaves or radiowaves to damage cancer cells in a way that may cause cell death.</li>
<li>Hypofractionated Image Guided Radiation Therapy (HIGRT) - In this treatment, beams of radiation enter the liver from multiple angles to treat the liver cancer over several treatment sessions (typically 5-10 treatments).</li></ul>
This study will last for about 8 months.

Locations

Duke University Hospital
Other

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

Phase II Non-Randomized Trial Comparing Interventional Radiology Liver Directed Therapies to Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients (PROVE-HCC)

Principal Investigator

Manisha
Palta

Protocol Number

PRO00089525

NCT ID

NCT04933435

Phase

II

Enrollment Status

Open to Enrollment