Clinical trial NCT03402607: Trial Comparing PLA to HIGRT (PROVE-HCC)
Official title: Phase II Randomized Trial Comparing Percutaneous Ablation to Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients (PROVE-HCC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Unresectable
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Durham VA Medical Center
name: Hunter Holmes McGuire VA Medical Center
First posted: 2018-01-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 Ablation (PLA) or Hypofractionated Image-Guided Radiation Therapy (HIGRT).

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in Quality of Life (QOL) Using EORTC C-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30)
timeFrame: Baseline to one month
Secondary outcomes:
measure: Change in Quality of Life (QOL) Using The Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Assessment
timeFrame: Baseline, 1 month, 3 months; change between baseline and 3 months reported
measure: Change in Quality of Life (QOL) Using EORTC QLQ C-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30)
timeFrame: Baseline to 3 months
measure: Change in Quality of Life (QOL) Using EORTC QLQ C-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30)
timeFrame: Baseline to 6 months
measure: Number of Participants With Grade 2 or Higher Adverse Events
timeFrame: Up to 90 days post treatment
measure: The Total Healthcare System Costs Associated With PLA vs HIGRT
timeFrame: From time of intervention to 90 days post treatment
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham Veterans Administration Medical Center (DVAMC)
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Manisha Palta, MD
role: PRINCIPAL_INVESTIGATOR
References: