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Trial Comparing PLA to HIGRT (PROVE-HCC) (PROVE-HCC)

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous Local Ablation
Hypofractionated Image Guided Radiation Therapy
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatocellular Carcinoma focused on measuring Unresectable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Durham Veterans Administration Medical Center (DVAMC)
  • Duke Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Percutaneous Local Ablation (PLA)

Hypofractionated Image-Guided Radiation Therapy (HIGRT)

Arm Description

A PLA procedure uses high-energy radio waves to treat liver tumors. Using CT and ultrasound guidance the doctor inserts a thin, needle-like probe into the liver tumor A high-frequency current is then passed through the tip of the probe, which heats the tumor with the goal to destroy the cancer cells. This may be done as an outpatient procedure or a short (1-2 day) hospital stay. PLA is the standard treatment for patients with liver cancer who cannot undergo liver surgery.

HIGRT is an emerging treatment option for patients with HCC; it utilizes external radiation where multiple beams enter the body from multiple angles to treat the liver cancer over typically 5-10 treatments while minimizing radiation to normal tissues. You will receive between 5-10 fractions (treatments) of radiation. Fraction size will be either 5 or 10 Gy (pronounced Gray, a standard unit of radiation measurement) depending on your tumor size and location or underlying liver function. The total dose of radiation is 50 Gy.

Outcomes

Primary Outcome Measures

Change in Quality of Life (QOL) Using EORTC C-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30)
To compare change in Quality of Life (QOL), as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) post treatment in patients receiving PLA vs HIGRT. The EORTC QLQ-C30 reports a Summary Score that is calculated from the mean of 13 of the 15 QLQ-C30 scales (excluding Global Quality of Life scale and the Financial Impact scale). 28 of the items have a range of 1 (not at all) to 4 (very much) and two of them have a range of 1 (very poor) to 7 (excellent). The total summary score ranges from 30 to 126, with lower scores indicating a better quality of life. Only the change in summary score is reported; no individual subscale scores are reported.

Secondary Outcome Measures

Change in Quality of Life (QOL) Using The Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Assessment
To compare change in Quality of Life (QOL), as measured by the FACT-Hep questionnaire post treatment in patients receiving PLA vs HIGRT from baseline to 1 month. The FACT-Hep Scale consists of five subscales: Physical well-being (PWB), Social/Family well-being (SWB), Emotional well-being (EWB), Functional well-being (FWB), and the Hepatobiliary Cancer Subscale (HCS). Total score ranges from 0 to 180, with higher scores indicating better quality of life. Average differences in each FACT-Hep Total Score for 3 months minus baseline are reported by treatment arm; no individual subscales are reported. An average difference > 0 indicates improvement in QOL at 3 versus baseline. An average difference < 0 indicates a worsening of QOL at 1 month versus baseline.
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)
To compare change in Quality of Life (QOL), as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) post treatment in patients receiving PLA vs HIGRT. The EORTC QLQ-C30 reports a Summary Score that is calculated from the mean of 13 of the 15 QLQ-C30 scales (excluding Global Quality of Life scale and the Financial Impact scale). 28 of the items have a range of 1 (not at all) to 4 (very much) and two of them have a range of 1 (very poor) to 7 (excellent). The total summary score ranges from 30 to 126, with lower scores indicating a better quality of life. Only the change in summary score is reported; no individual subscale scores are reported.
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)
To compare change in Quality of Life (QOL), as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) post treatment in patients receiving PLA vs HIGRT. To compare change in Quality of Life (QOL), as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) post treatment in patients receiving PLA vs HIGRT. The EORTC QLQ-C30 reports a Summary Score that is calculated from the mean of 13 of the 15 QLQ-C30 scales (excluding Global Quality of Life scale and the Financial Impact scale). 28 of the items have a range of 1 (not at all) to 4 (very much) and two of them have a range of 1 (very poor) to 7 (excellent). The total summary score ranges from 30 to 126, with lower scores indicating a better quality of life. Only the change in summary score is reported; no individual subscale scores are reported.
Number of Participants With Grade 2 or Higher Adverse Events
Grade ≥2 acute toxicity within 90 days of treatment initiation for each treatment as defined by the CTCAE v4.0
The Total Healthcare System Costs Associated With PLA vs HIGRT
Healthcare system costs estimated based on national averages for billable charges for all codes associated with PLA vs HIRGT throughout the course of treatment through 90 days post treatment.

Full Information

First Posted
January 11, 2018
Last Updated
July 5, 2022
Sponsor
Duke University
Collaborators
Durham VA Medical Center, Hunter Holmes McGuire VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03402607
Brief Title
Trial Comparing PLA to HIGRT (PROVE-HCC)
Acronym
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
July 25, 2019 (Actual)
Study Completion Date
March 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Durham VA Medical Center, Hunter Holmes McGuire VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Unresectable

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous Local Ablation (PLA)
Arm Type
Active Comparator
Arm Description
A PLA procedure uses high-energy radio waves to treat liver tumors. Using CT and ultrasound guidance the doctor inserts a thin, needle-like probe into the liver tumor A high-frequency current is then passed through the tip of the probe, which heats the tumor with the goal to destroy the cancer cells. This may be done as an outpatient procedure or a short (1-2 day) hospital stay. PLA is the standard treatment for patients with liver cancer who cannot undergo liver surgery.
Arm Title
Hypofractionated Image-Guided Radiation Therapy (HIGRT)
Arm Type
Active Comparator
Arm Description
HIGRT is an emerging treatment option for patients with HCC; it utilizes external radiation where multiple beams enter the body from multiple angles to treat the liver cancer over typically 5-10 treatments while minimizing radiation to normal tissues. You will receive between 5-10 fractions (treatments) of radiation. Fraction size will be either 5 or 10 Gy (pronounced Gray, a standard unit of radiation measurement) depending on your tumor size and location or underlying liver function. The total dose of radiation is 50 Gy.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Local Ablation
Other Intervention Name(s)
Microwave Ablation (MWA)
Intervention Description
Microwave Ablation (MWA) is a form of percutaneous localized ablation using thermal ablation techniques to treat cancer via direct coagulative necrosis. Microwaves can generate high temperatures in a short period of time; MWA has the potential to improve treatment efficacy over radiofrequency ablation as it can be used to treat larger lesions and has less susceptibility to heat-sink due to vessel proximity. MWA uses electromagnetic waves (300 MHz to 300 GHz) to produce oscillation of polar molecules within tissue; this generates tissue necrosis through frictional heating. For HCC, one or more microwave antennae are inserted into the liver, usually under the guidance of ultrasonography or computed tomography (CT). Frequency and length of treatment is determined on a case by case basis depending on tumor size and proximity to vessels or other organs at risk.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Image Guided Radiation Therapy
Other Intervention Name(s)
HIGRT
Intervention Description
HIGRT represents the only non-invasive curative modality in the management of HCC. HCC patients typically have a host of other medical comorbidities complicated by underlying liver dysfunction that makes the implementation of liver-directed therapy challenging. Presently HIGRT is typically offered only after alternative surgical (transplantation/hepatectomy) and non-operative approaches (PLA/embolization) have been exhausted.
Primary Outcome Measure Information:
Title
Change in Quality of Life (QOL) Using EORTC C-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30)
Description
To compare change in Quality of Life (QOL), as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) post treatment in patients receiving PLA vs HIGRT. The EORTC QLQ-C30 reports a Summary Score that is calculated from the mean of 13 of the 15 QLQ-C30 scales (excluding Global Quality of Life scale and the Financial Impact scale). 28 of the items have a range of 1 (not at all) to 4 (very much) and two of them have a range of 1 (very poor) to 7 (excellent). The total summary score ranges from 30 to 126, with lower scores indicating a better quality of life. Only the change in summary score is reported; no individual subscale scores are reported.
Time Frame
Baseline to one month
Secondary Outcome Measure Information:
Title
Change in Quality of Life (QOL) Using The Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Assessment
Description
To compare change in Quality of Life (QOL), as measured by the FACT-Hep questionnaire post treatment in patients receiving PLA vs HIGRT from baseline to 1 month. The FACT-Hep Scale consists of five subscales: Physical well-being (PWB), Social/Family well-being (SWB), Emotional well-being (EWB), Functional well-being (FWB), and the Hepatobiliary Cancer Subscale (HCS). Total score ranges from 0 to 180, with higher scores indicating better quality of life. Average differences in each FACT-Hep Total Score for 3 months minus baseline are reported by treatment arm; no individual subscales are reported. An average difference > 0 indicates improvement in QOL at 3 versus baseline. An average difference < 0 indicates a worsening of QOL at 1 month versus baseline.
Time Frame
Baseline, 1 month, 3 months; change between baseline and 3 months reported
Title
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)
Description
To compare change in Quality of Life (QOL), as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) post treatment in patients receiving PLA vs HIGRT. The EORTC QLQ-C30 reports a Summary Score that is calculated from the mean of 13 of the 15 QLQ-C30 scales (excluding Global Quality of Life scale and the Financial Impact scale). 28 of the items have a range of 1 (not at all) to 4 (very much) and two of them have a range of 1 (very poor) to 7 (excellent). The total summary score ranges from 30 to 126, with lower scores indicating a better quality of life. Only the change in summary score is reported; no individual subscale scores are reported.
Time Frame
Baseline to 3 months
Title
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)
Description
To compare change in Quality of Life (QOL), as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) post treatment in patients receiving PLA vs HIGRT. To compare change in Quality of Life (QOL), as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) post treatment in patients receiving PLA vs HIGRT. The EORTC QLQ-C30 reports a Summary Score that is calculated from the mean of 13 of the 15 QLQ-C30 scales (excluding Global Quality of Life scale and the Financial Impact scale). 28 of the items have a range of 1 (not at all) to 4 (very much) and two of them have a range of 1 (very poor) to 7 (excellent). The total summary score ranges from 30 to 126, with lower scores indicating a better quality of life. Only the change in summary score is reported; no individual subscale scores are reported.
Time Frame
Baseline to 6 months
Title
Number of Participants With Grade 2 or Higher Adverse Events
Description
Grade ≥2 acute toxicity within 90 days of treatment initiation for each treatment as defined by the CTCAE v4.0
Time Frame
Up to 90 days post treatment
Title
The Total Healthcare System Costs Associated With PLA vs HIGRT
Description
Healthcare system costs estimated based on national averages for billable charges for all codes associated with PLA vs HIRGT throughout the course of treatment through 90 days post treatment.
Time Frame
From time of intervention to 90 days post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manisha Palta, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham Veterans Administration Medical Center (DVAMC)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Trial Comparing PLA to HIGRT (PROVE-HCC)

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