An interventional study of Percutaneous Local Ablation and Hypofractionated Image Guided Radiation Therapy in Hepatocellular Carcinoma, sponsored by Duke University. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-08.
Sponsored by Duke University · Not applicable, Interventional, and Other
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).
Exclusion Criteria:
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
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
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)
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
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.
Time frame: Baseline to one month
Change in Quality of Life (QOL) Using The Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Assessment
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: Baseline to 6 months
Number of Participants With Grade 2 or Higher Adverse Events
Grade ≥2 acute toxicity within 90 days of treatment initiation for each treatment as defined by the CTCAE v4.0
Time frame: Up to 90 days post treatment
The Total Healthcare System Costs Associated With PLA vs HIGRT
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.
Time frame: From time of intervention to 90 days post treatment
| Milestone | Percutaneous Local Ablation (PLA) | Hypofractionated Image-Guided Radiation Therapy (HIGRT) |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
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.
| score on a scale | Percutaneous Local Ablation (PLA) | Hypofractionated Image-Guided Radiation Therapy (HIGRT) |
|---|---|---|
| Change in Quality of Life (QOL) Using EORTC C-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30) | -6.25 (-14.90 to 2.40) | -10.00 (-26.21 to 6.21) |
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.
| score on a scale | Percutaneous Local Ablation (PLA) | Hypofractionated Image-Guided Radiation Therapy (HIGRT) |
|---|---|---|
| Change in Quality of Life (QOL) Using The Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Assessment | -14.25 (-39.85 to 11.35) | 0.4 (-34.15 to 33.35) |
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.
| score on a scale | Percutaneous Local Ablation (PLA) | Hypofractionated Image-Guided Radiation Therapy (HIGRT) |
|---|---|---|
| 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) | -6.75 (-19.37 to 5.87) | -12.00 (-30.41 to 6.41) |
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.
| difference in scores on a scale | Percutaneous Local Ablation (PLA) | Hypofractionated Image-Guided Radiation Therapy (HIGRT) |
|---|---|---|
| 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) | -11.00 (-26.85 to 4.81) | -9.20 (-30.51 to 12.11) |
Grade ≥2 acute toxicity within 90 days of treatment initiation for each treatment as defined by the CTCAE v4.0
| Participants | Percutaneous Local Ablation (PLA) | Hypofractionated Image-Guided Radiation Therapy (HIGRT) |
|---|---|---|
| Number of Participants With Grade 2 or Higher Adverse Events | 1 | 1 |
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.
No measurements were reported for this outcome.
Collected over 90 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Percutaneous Local Abalation (PLA) | 0/6 (0%) | 2/6 (33.3%) | 0/6 (0%) |
| Hypofractionated Image-Guided Radiation Therapy (HIGRT) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) |
| Event | Percutaneous Local Abalation (PLA) | Hypofractionated Image-Guided Radiation Therapy (HIGRT) |
|---|---|---|
| HospitalizationGeneral disorders | 2/6 | 1/6 |
| Event | Percutaneous Local Abalation (PLA) | Hypofractionated Image-Guided Radiation Therapy (HIGRT) |
|---|---|---|
| FatigueGeneral disorders | 0/6 | 1/6 |
| Flu like symptomsGeneral disorders | 0/6 | 1/6 |
| DizzinessNervous system disorders | 0/6 | 1/6 |
| DiarrheaGastrointestinal disorders | 0/6 | 1/6 |
| Age, Categorical(Participants) | Percutaneous Local Ablation (PLA) | Hypofractionated Image-Guided Radiation Therapy (HIGRT) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 3 | 5 |
| >=65 years | 4 | 3 | 7 |
| Age, Continuous(years) | Percutaneous Local Ablation (PLA) | Hypofractionated Image-Guided Radiation Therapy (HIGRT) | Total |
|---|---|---|---|
| Mean | 66.8 ± 7.4 | 65.3 ± 5.4 | 66.1 ± 6.5 |
| Sex: Female, Male(Participants) | Percutaneous Local Ablation (PLA) | Hypofractionated Image-Guided Radiation Therapy (HIGRT) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 6 | 6 | 12 |
| Race (NIH/OMB)(Participants) | Percutaneous Local Ablation (PLA) | Hypofractionated Image-Guided Radiation Therapy (HIGRT) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 2 | 5 |
| White | 3 | 3 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Percutaneous Local Ablation (PLA) | Hypofractionated Image-Guided Radiation Therapy (HIGRT) | Total |
|---|---|---|---|
| United States | 6 | 6 | 12 |
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Duke University