Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib
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|ClinicalTrials.gov Identifier: NCT04327700|
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : December 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Device: TheraBionic Drug: Regorafenib||Phase 2|
Primary Objective: To estimate progression-free survival rates.
- To obtain information concerning the feasibility of administration of the proposed treatment, including patient participation in trials using the proposed treatment.
- To evaluate safety and tolerability in this patient population.
- To evaluate the effect on levels of alpha-fetoprotein.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib as Second-line Therapy For Patients With Advanced Hepatocellular Carcinoma.|
|Actual Study Start Date :||January 26, 2021|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||May 2022|
Experimental: Regorafenib and TheraBionic
TheraBionic is a device that consists of battery-driven radiofrequency electromagnetic field generator. The metal mouth spoon antenna is placed on the anterior part of the tongue during treatment.
Regorafenib is a 40 mg tablet administered orally.
Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three courses of 60-minute treatments per day, administered in the morning, at noon and in the evening at the patient's home, with the exception of the first 60-minute treatment, which will be delivered at the research site. Each 4 week treatment period will be considered a cycle of treatment.
Other Name: Amplitude-modulated electromagnetic field device
Patients will receive 160 mg regorafenib (four 40 mg tablets) orally once daily for the first 3 weeks of each 4-week cycle per approved prescribing information.
Other Name: Stivarga
- Progression-Free Survival [ Time Frame: 12 weeks ]Progression-free survival will be estimated along with estimates of 95% confidence intervals for the treatment group. In addition, we will determine the proportion of patients who are progression free after 12 weeks (after 2nd 6-week visit) and compare this to the proportion of patients that were described as progression free in the RESORCE trial using a Simon's two stage design.
- Overall Survival [ Time Frame: 6 months ]Kaplan Meier curves for patients survival and also estimate the percent of patients who are alive at 6 months and the corresponding 95% Clopper Pearson exact confidence intervals will be calculated.
- Percentage of Participants with Disease Control [ Time Frame: At 4 months and at 6 months from the date of enrollment ]Disease control is defined as the percentage of participants alive and have documented response status of complete response, partial response or stable disease according to the modified RECIST (mRECIST) for hepatocellular carcinoma using a 95% Clopper Pearson exact confidence interval. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of longest diameters of target lesions, without evidence of disease progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
- Incidences of Adverse Events [ Time Frame: Up to 30 days after treatment ends ]Type, incidence, severity of adverse events graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse events will be described for each CTL type for this study using counts/percent's.
- Comparison of Adverse Events (WFBCCC 55319 to RESORCE historical trial) [ Time Frame: Up to 30 days after treatment ends ]
Type, incidence, severity of adverse events graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Adverse events will be compared for each CTL type for the treatment group (WFBCCC 55319 study) and historical control (from the RESORCE trial), using the Fisher's exact test (two-sided) at level 0.05. These comparisons will be made to compare events of grade greater than or equal to 3 between each group.
- Change in Alpha-fetoprotein Levels [ Time Frame: 6 months ]Average alpha-fetoprotein level 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 alpha-fetoprotein level differs by response category.
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): NCT04327700
|Contact: Austin Humbert, CRCemail@example.com|
|Contact: Stacie Moore, CRNfirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest Baptist Comprehensive Cancer Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Study Coordinator email@example.com|
|Principal Investigator: William Blackstock, MD|
|Principal Investigator:||William Blackstock, MD||Wake Forest University Health Sciences|