Trial Comparing PLA to HIGRT (PROVE-HCC)

Duke University

Status: Terminated

Conditions: Hepatocellular Carcinoma

Treatments: Radiation: Hypofractionated Image Guided Radiation Therapy; Procedure: Percutaneous Local Ablation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03402607

Pro00089525

Details and patient eligibility

About

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).

Full description

Administrative clarification:

This clinical trial was terminated due to poor enrollment and was replaced by a separate non-randomized trial (NCT04933435).

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Percutaneous Local Ablation (PLA)

Active Comparator group

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.

Treatment:

Procedure: Percutaneous Local Ablation

Hypofractionated Image-Guided Radiation Therapy (HIGRT)

Active Comparator group

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.

Treatment:

Radiation: Hypofractionated Image Guided Radiation Therapy