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

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ClinicalTrials.gov Identifier: NCT03402607
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : January 9, 2019
Sponsor:
Collaborators:
Durham VA Medical Center
Hunter Holmes McGuire VA Medical Center
Information provided by (Responsible Party):
Duke University

Brief Summary:
This phase II, randomized trial will 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).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: Percutaneous Local Abalation Radiation: Hypofractionated Image Guided Radaition Therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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)
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2025

Arm Intervention/treatment
Active Comparator: Percutaneous Local Abalation (PLA)
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 Abalation
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.
Other Name: Microwave Abalation (MWA)

Active Comparator: Hypofractionated Image-Guided Radiation Therapy (HIGRT)
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 Radaition Therapy
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.
Other Name: HIGRT




Primary Outcome Measures :
  1. Quality of Life (QOL) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Quality of Life (QOL) [ Time Frame: Baseline to 3 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.

  2. Quality of Life (QOL) [ Time Frame: 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.

  3. Quality of Life [ Time Frame: Baseline to one month ]
    To compare change in Quality of Life (QOL), as measured by the FACT-Hep questionnaire post treatment in patients receiving PLA vs HIGRT.

  4. Acute toxicity: Assess patients for grade 2 or higher acute toxicity as defined by the CTCAE v4.0 [ Time Frame: Up to 90 days post treatment ]
    Assess patients for grade 2 or higher acute toxicity as defined by the CTCAE v4.0

  5. Financial toxicity: Assess the total healthcare system cost associated with PLA vs HIGRT [ Time Frame: From time of intervention to 90 days post treatment ]
    Assess the total healthcare system cost associated with PLA vs HIGRT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has signed informed consent
  • At least 1 solid liver lesion with arterial enhancement and delayed wash-out on multi-phasic computerized tomography (CT) or magnetic resonance imaging (MRI) characteristic of hepatocellular carcinoma.
  • HCC diagnosed either by histology/pathology or Liver Imaging Reporting and Data System (LIRADs 5 per the ACR's LIRADs criteria10)
  • Patient is 18 years or older
  • ECOG Performance status of 0-2
  • Child Pugh score A or B
  • Lesions less than or equal to 5cm in size
  • Less than or equal to 3 lesions in the liver
  • 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

Exclusion Criteria:

  • Child Pugh score C
  • Fluctuating ascites
  • Inability to complete baseline QOL forms
  • Concurrent administration of systemic therapy for HCC
  • Prior liver RT must be approved by the PI
  • Positive serum pregnancy test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402607


Contacts
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Contact: Heather Franklin, BSN OCN 919 6683726 heather.franklin@dm.duke.edu
Contact: Joan Cahill, BNS OCN CCRP 919 6683726

Locations
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United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Heather Franklin, RN BSN    919 6683726      
Contact: Joan Cahill, BNS OCN CCRP    919 6683726      
Principal Investigator: Manisha Palta, MD         
Sponsors and Collaborators
Duke University
Durham VA Medical Center
Hunter Holmes McGuire VA Medical Center
Investigators
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Principal Investigator: Manisha Palta, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03402607     History of Changes
Other Study ID Numbers: Pro00089525
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
Unresectable

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases