Status:
TERMINATED
Trial Comparing PLA to HIGRT (PROVE-HCC)
Lead Sponsor:
Duke University
Collaborating Sponsors:
Durham VA Medical Center
Hunter Holmes McGuire VA Medical Center
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This phase II, randomized trial compare Quality of Life for patients with Hepatocellular Carcinoma (HCC) who are not surgical candidates or decline surgery and are treated with Percutaneous Local Abla...
Detailed Description
Administrative clarification: This clinical trial was terminated due to poor enrollment and was replaced by a separate non-randomized trial (NCT04933435).
Eligibility Criteria
Inclusion
- HCC diagnosed either by histology/pathology or Liver Imaging Reporting and Data System (LIRADs 5 per the ACR's LIRADs criteria) by CT or MRI
- Patient is 18 years or older
- ECOG Performance status of 0-2
- Child Pugh score A5, A6, B7 or B8
- Lesions less than or equal to 5cm in size
- Less than or equal to 3 lesions in the liver to be treated on protocol
- Lesion amenable to treatment with both PLA and HIGRT; for PLA treatment this requires the lesion be visible via ultrasound and/or non-contrast CT or feasible per treating physician
Exclusion
- Child Pugh score B9 or Class C
- Fluctuating ascites
- Inability to complete baseline QOL forms
- Concurrent administration of systemic therapy for HCC
- Prior liver RT is an exclusion unless subject participation is approved by the PI
- Positive serum pregnancy test
Key Trial Info
Start Date :
August 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03402607
Start Date
August 8 2018
End Date
March 25 2020
Last Update
July 8 2022
Active Locations (2)
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1
Durham Veterans Administration Medical Center (DVAMC)
Durham, North Carolina, United States, 27705
2
Duke Cancer Center
Durham, North Carolina, United States, 27710