Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

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.

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.

Percutaneous Local Ablation

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.

Hypofractionated Image Guided Radiation Therapy

Manisha Palta, MD

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).

Administrative clarification:

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

Trial Comparing PLA to HIGRT (PROVE-HCC)

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)

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.

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.

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.

Grade ≥2 acute toxicity within 90 days of treatment initiation for each treatment as defined by the CTCAE v4.0

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.

Durham VA Medical Center

Hunter Holmes McGuire VA Medical Center

Duke University

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.

Percutaneous Local Ablation: 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.

Percutaneous Local Abalation (PLA)

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.

Hypofractionated Image Guided Radiation 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.

Hypofractionated Image-Guided Radiation Therapy (HIGRT)

Percutaneous Local Ablation (PLA)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Linda Kaltenbach

Participants who completed the EORTC C-30 at both time points.

Change in Quality of Life (QOL) Using EORTC C-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30)

Participants who completed the FACT-Hep at both time points.

Change in Quality of Life (QOL) Using The Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Assessment

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)

Spots Global Cancer Trial Database for Trial Comparing PLA to HIGRT (PROVE-HCC)

Trial Identification

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Study Description

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