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.
Who Can Participate?
Eligibility
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
-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 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:
- 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
- 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
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 ACCRUAL