PROVE-HCC: A study for People with Liver Cancer - Clinical Trial

What is the Purpose of this Study?

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

What is the Condition Being Studied?

Liver cancer

Who Can Participate in the Study?

Adults who:

-Are diagnosed with 1-3 liver tumors that are less than or equal to 5cm in size

-Can be treated with either PLA or HIGRT

-Have a negative pregnancy test

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

- Be randomly (like drawing numbers from a hat) assigned to one of the following standard of care treatments:

1. Percutaneous Local Ablation (PLA)- This treatment involves inserting special needles into the liver cancer and using microwaves or radiowaves to damage cancer cells in a way that may cause cell death.

2. 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).

- You will be asked to complete two quality of life surveys before treatment and after treatment at one, three and six months, for a total of four times.

- Be involved in this study for about 8 months

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
Radiation Oncologist
Protocol Number
IRB: PRO00089525
NCT: NCT04933435
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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