Trial Comparing PLA to HIGRT (PROVE-HCC)

NCT03402607 | Terminated Results

• 1 other identifier: Pro00089525
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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).

Conditions

Hepatocellular Carcinoma

Keywords

Unresectable

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to one month

Secondary Outcomes (5)

• 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

• 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 3 months

• 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

• Number of Participants With Grade 2 or Higher Adverse Events

  Up to 90 days post treatment

• The Total Healthcare System Costs Associated With PLA vs HIGRT

  From time of intervention to 90 days post treatment

Study Arms (2)

Percutaneous Local Ablation (PLA)

ACTIVE COMPARATOR

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.

Procedure: Percutaneous Local Ablation

Hypofractionated Image-Guided Radiation Therapy (HIGRT)

ACTIVE COMPARATOR

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.

Radiation: Hypofractionated Image Guided Radiation Therapy

Interventions

Percutaneous Local Ablation PROCEDURE

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.

Also known as: Microwave Ablation (MWA)

Percutaneous Local Ablation (PLA)

Hypofractionated Image Guided Radiation Therapy RADIATION

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.

Also known as: HIGRT

Hypofractionated Image-Guided Radiation Therapy (HIGRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Child Pugh score B9 or Class C
• Fluctuating ascites
• Inability to complete baseline QOL forms
• Concurrent administration of systemic therapy for HCC
• Positive serum pregnancy test

Sponsors & Collaborators

• Duke University: lead
• Durham VA Medical Center: collaborator
• Hunter Holmes McGuire VA Medical Center: collaborator

Study Sites (2)

Durham Veterans Administration Medical Center (DVAMC)

Durham, North Carolina, 27705, United States

Location

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Linda Kaltenbach
• Organization: Duke University Health System

Linda.Kaltenbach@duke.edu

919-681-6804

Study Officials

• Manisha Palta, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 18, 2018
• Study Start: August 8, 2018
• Primary Completion: July 25, 2019
• Study Completion: March 25, 2020
• Last Updated: July 8, 2022
• Results First Posted: December 6, 2021

Record last verified: 2022-07

Locations

US (2)