The goal of this clinical trial is to learn if adding amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) to Fruquintinib in metastatic colorectal cancer that has not responded to other standard treatment is: * Effective in improving survival * safe and tolerable
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Fruquintinib is a small molecule tyrosine kinase inhibitor (TKI) that targets VEGFR-1, -2, and -3, with a novel chemical structure which belongs to the quinazoline class
TheraBionic P1 is a amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) device
Karmanos Cancer Institute at McLaren Bay Region
Bay City, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, United States
RECRUITINGOverall Survival (OS)
Overall survival (OS) is defined as the time duration from treatment start until death of any cause. The distribution of OS will be graphically summarized by a Kaplan-Meier (KM) curve, and median OS (mOS) and its one-sided 85% (i.e., two-sided 70%) confidence interval (CI) will be estimated using KM estimates.
Time frame: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first
Safety and Tolerability
Analyses will be performed for all participants who have received fruquintinib and TheraBionic P1 treatment. AEs will be graded based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Adverse Events will be summarized by count and frequency. Corresponding two-sided 95% CI will be calculated using Clopper and Pearson's method.
Time frame: From start of treatment to 28 days post device discontinuation
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time duration from treatment start to progression or death of any cause. Progression of disease will be assessed and determined by the treating investigator. A one-sample log-rank test will be performed to evaluate PFS. The distribution of PFS will be graphically summarized by Kaplan-Meier (KM) curve and median PFS (mPFS) and its 95% CI will be estimated using KM estimates.
Time frame: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first
Rates of progressive disease
The proportions of participants whose disease has progressed after treatment initiation will be computed by dividing the number of participants with progression by the total number of patients who were followed.
Time frame: From start of treatment to 5 years after treatment initiation or death, whichever comes first
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Karmanos Cancer Institute
Detroit, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Flint
Flint, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Macomb
Macomb, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Northern Michigan, Petoskey
Petoskey, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, United States
RECRUITINGChanges in serum Carcinoembryonic Antigen (CEA)
Serum CEA will be measured at baseline, on Day 1 of each cycle, and at the end of treatment. Distribution of levels of serum CEA will be checked and, if needed, data transformation will be employed for normality. The levels of serum CEA will be descriptively summarized using mean, median, standard deviation (SD), range, and 95% CI per each time point. The changes in serum CEA will be also descriptively summarized using the same descriptive statistics. The associations between the change of serum CEA and each of efficacy outcomes will be descriptively evaluated using logistic and Cox proportional hazard regression models. The proportional hazard assumption will be checked and, if violated, a weighed Cox regression model or restricted mean survival time will be utilized.
Time frame: Through study completion, up to 1 year
Changes in serum microRNA (miRNA)
Serum miRNA levels will be assessed at baseline, on Day 1 of the first two cycles, and a final sample will be collected at progression or end of treatment (whichever comes first). The distribution of levels of serum microRNA will be checked and, if needed, data transformation will be employed for normality. The levels of serum miRNA will be descriptively summarized using differential expression (DE) fold change \> 2 p0.05 and 95% CI for each timepoint. The changes in serum miRNA will be also descriptively summarized using the same descriptive statistics. The associations between the change of serum miRNA and each of the efficacy outcomes (OS and PFS) will be descriptively evaluated using logistic and Cox proportional hazard regression models. The proportional hazard assumption will be checked and, if violated, a weighed Cox regression model or restricted mean survival time will be utilized.
Time frame: Through study completion, up to 1 year