Trial Comparing PLA to HIGRT (PROVE-HCC)

Not Applicable

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Radiation: Hypofractionated Image Guided Radiation Therapy; Procedure: Percutaneous Local Ablation

• Registration Number: NCT03402607
• Lead Sponsor: Duke University

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).

Study Timeline

• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-18
• Study Start: 2018-08-08
• Primary Completion: 2019-07-25
• Study Completion: 2020-03-25
• Results First Submitted: 2021-10-26
• Results First Submitted QC: 2021-10-26
• Results First Posted: 2021-12-06
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypofractionated Image-Guided Radiation Therapy (HIGRT)	Hypofractionated Image Guided Radiation Therapy	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.
Percutaneous Local Ablation (PLA)	Percutaneous Local Ablation	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.

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life (QOL) Using EORTC C-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30)	Baseline to one month	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

Name	Time	Method
Change in Quality of Life (QOL) Using The Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Assessment	Baseline, 1 month, 3 months; change between baseline and 3 months reported	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)	Baseline to 6 months	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	Up to 90 days post treatment	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	From time of intervention to 90 days post treatment	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.

Trial Locations

Locations (2)

Durham Veterans Administration Medical Center (DVAMC); 🇺🇸 Durham, North Carolina, United States

Duke Cancer Center; 🇺🇸 Durham, North Carolina, United States