The primary goals of this study are to compare overall survival and quality of life in subjects with Child-Pugh A or B advanced hepatocellular carcinoma when treated with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
Primary Objectives To compare the overall survival between subjects with advanced hepatocellular carcinoma treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies. To compare the patient-reported disease-related symptoms between subjects with advanced hepatocellular carcinoma treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies. Secondary Objectives To compare progression-free survival between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies. To compare safety and tolerability between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies. To compare the effect on levels of alpha-fetoprotein between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies. To compare global treatment side effect bother between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies. To compare patient-rated symptomatic adverse events between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
166
Each treatment day consists of three courses of 60-minute treatments to be administered in the morning, at noon, and in the evening. Each 6-week treatment period will be considered a cycle of treatment. With the exception of the first 60-minute treatment, which will be delivered at one of the recruiting site, all other treatments will be self-administered at the patient's home.
Each treatment day consists of three courses of 60-minute treatments to be administered in the morning, at noon, and in the evening. Each 6-week treatment period will be considered a cycle of treatment. With the exception of the first 60-minute treatment, which will be delivered at the recruiting site, all other treatments will be self-administered at the patient's home.
Tampa General Hospital, Tampa General Cancer Center
Tampa, Florida, United States
NOT_YET_RECRUITINGRobert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
NOT_YET_RECRUITINGWake Forest Baptist Comprehensive Cancer Center
Overall Survival
Overall survival assessment will be recorded in days and will represent the period starting at the date of treatment initiation and finishing at the date of patient death. Living patients at the time of analysis will have the date of last contact (consultation visit or phone contact) used to define overall survival.
Time frame: Baseline to 6 months
Quality of Life Survey
Patient-reported hepatobiliary-specific disease-related symptoms will be assessed by the 18-item FACT-Hepatobiliary (Hep) subscale every cycle for the first 6 cycles then every other cycle thereafter, at the end of treatment, and at every 3 months during follow-up.
Time frame: Baseline to 6 months
Progression-Free Survival
Progression free survival (PFS) will be compared between groups using a 2-sided log rank test. Kaplan-Meier survival curves for PFS will also be generated and median progression free survival and corresponding 95% confidence intervals will be estimated for each group
Time frame: Up to 2 years
Proportion of Patients With Disease Control
Proportion of patients who respond and the corresponding 95% Clopper Pearson exact confidence intervals. Patients who are removed from study before the 6-month time point will be considered to not have disease control at that time point.
Time frame: At 4 months and 6 months and up to 2 years
Proportion of Participants That Are Progression Free
we will determine the proportion of patients who are progression free after 12 weeks (after 2nd 6-week visit) and compare this between groups using a Fisher's exact test. In addition, the corresponding 95% Clopper Pearson exact confidence intervals will be calculated for the 4 month and 6 month progression free survival rates.
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Ancillary services
Winston-Salem, North Carolina, United States
Oregon Health & Science University, Knight Cancer Institute
Portland, Oregon, United States
NOT_YET_RECRUITINGThomas Jefferson University Hospital, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGDHR Health Advanced Care Center, DHR Oncology Institute
Edinburg, Texas, United States
NOT_YET_RECRUITINGUniversity of Texas Health Science Center, Mays Cancer Center
San Antonio, Texas, United States
NOT_YET_RECRUITINGTime frame: At 12 weeks, 4 months and 6 months and up to 2 years
Incidences of Adverse Events - CTCAE version 5.0
Using Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0, type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities will be assessed.
Time frame: Up to 28 days after study treatment administration or until death
Changes in Alfa-Fetoprotein Levels
Investigators will examine whether these is any association between the AFP levels (potential biomarker for response) and the objective response observed for each participant. Average alfa-fetoprotein levels will be examined over time, and these changes in alfa-fetoprotein rates after 6 months will be examined for each Response category (complete response/ partial response/ stable disease/ progressive disease) and tested using a 1-way ANOVA to see if the change in AFP level differs by response category.
Time frame: 6 months
Functional Assessment of Cancer Therapy-General (FACT-G) Item GP5
Participants will answer a single item question from the FACT-G questionnaire "I am bothered by side effects of treatment" Scoring scale of 0 (not at all) to 4 (very much) to assess for side effects to assess for patient rated treatment tolerability.
Time frame: At baseline and every 6 weeks up to 6 months
Frequency of Adverse Events - PRO-CTCAE
The frequency and nature of patient-reported symptomatic adverse events will be assessed using 10 items from the PRO-CTCAE item library. PRO-CTCAE items will assess mucositis (2 items; severity, interference), dry mouth (1 item, severity), fatigue (2 items; severity, interference), decreased appetite (2 items; severity, interference), nausea (1 item, severity), and headache (2 items; severity, interference) to measure potential adverse events associated with the study intervention. Participants will select the one response that best describes their experience with a scoring scale(s) of None to Very Severe or Not at all to Very Much.
Time frame: At baseline and every 8 weeks up to 6 months