Trial Outcomes & Findings for Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma (NCT NCT01005875)

NCT ID: NCT01005875

Last Updated: 2017-05-10

Results Overview

Number of subjects experiencing a Grade 5 toxicity related to SBRT and sorafenib

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: between baseline and 3 years
• Results posted on: 2017-05-10

Participant Flow

Participant milestones

Measure	Radiation Followed by Sorafenib Radiation therapy, stereotactic body radiation therapy followed by Sorafenib Sorafenib: Nexavar in bottles of 120 tables Stereotactic Body Radiotherapy (SBRT): SBRT
Overall Study STARTED	5
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Radiation Followed by Sorafenib Radiation therapy, stereotactic body radiation therapy followed by Sorafenib Sorafenib: Nexavar in bottles of 120 tables Stereotactic Body Radiotherapy (SBRT): SBRT
Overall Study Death	3

Baseline Characteristics

Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma

Baseline characteristics by cohort

Measure	Radiation Followed by Sorafenib n=5 Participants Radiation therapy, stereotactic body radiation therapy followed by Sorafenib Sorafenib: Nexavar in bottles of 120 tables Stereotactic Body Radiotherapy (SBRT): SBRT
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: between baseline and 3 years

Number of subjects experiencing a Grade 5 toxicity related to SBRT and sorafenib

Outcome measures

Measure	Radiation Followed by Sorafenib n=2 Participants Radiation therapy, stereotactic body radiation therapy followed by Sorafenib Sorafenib: Nexavar in bottles of 120 tables Stereotactic Body Radiotherapy (SBRT): SBRT
Determine the Safety and Tolerability of Sequential SBRT and Sorafenib in Patients With Unresectable Hepatocellular Carcinoma	2 participants

SECONDARY outcome

Timeframe: baseline, 4 weeks and 10 weeks

mean tumor volume at baseline, 4 weeks and 10 weeks after start of treatment

Outcome measures

Measure	Radiation Followed by Sorafenib n=2 Participants Radiation therapy, stereotactic body radiation therapy followed by Sorafenib Sorafenib: Nexavar in bottles of 120 tables Stereotactic Body Radiotherapy (SBRT): SBRT
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Tumor Volume at 4 weeks after baseline	65 centimeters^3 Standard Deviation 42
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Tumor Volume at baseline	98 centimeters^3 Standard Deviation 71
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Tumor Volume at 10 weeks after baseline	22 centimeters^3 Standard Deviation 8

SECONDARY outcome

Timeframe: baseline, 4 weeks and 10 weeks

The initial mean Ktrans at baseline, 4 weeks and 10 week. K trans is used to describe the uptake of gadolinium contrast in tissue.

Outcome measures

Measure	Radiation Followed by Sorafenib n=2 Participants Radiation therapy, stereotactic body radiation therapy followed by Sorafenib Sorafenib: Nexavar in bottles of 120 tables Stereotactic Body Radiotherapy (SBRT): SBRT
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Ktrans (Volume Transfer Coefficient). at baseline	0.022 min^ -1 Standard Deviation 0.009
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Ktrans (Volume Transfer Coefficient). at 4 weeks after baseline	0.017 min^ -1 Standard Deviation 0.009
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Ktrans (Volume Transfer Coefficient). at 10 weeks after baseline	0.014 min^ -1 Standard Deviation 0.006

SECONDARY outcome

Timeframe: baseline, 4 weeks after baseline and 10 weeks post baseline

The Kep as measures by MRI at baseline, 4 weeks after baseline, and 10 weeks after baseline.

Outcome measures

Measure	Radiation Followed by Sorafenib n=2 Participants Radiation therapy, stereotactic body radiation therapy followed by Sorafenib Sorafenib: Nexavar in bottles of 120 tables Stereotactic Body Radiotherapy (SBRT): SBRT
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Kep. Kep Describes How Fast Contrast Can Redistribute in Tissue. at baseline	0.062 Min^ -1 Standard Deviation 0.018
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Kep. Kep Describes How Fast Contrast Can Redistribute in Tissue. at 4 weeks after baseline	0.053 Min^ -1 Standard Deviation 0.013
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Kep. Kep Describes How Fast Contrast Can Redistribute in Tissue. at 10 weeks after baseline	0.050 Min^ -1 Standard Deviation 0.014

SECONDARY outcome

Timeframe: baseline, 4 weeks post baseline, 10 weeks post baseline

the measured ADC at baseline, 4 weeks after baseline and then 10 weeks after baseline. ADC quantifies the motion of water protons from an MRI.

Outcome measures

Measure	Radiation Followed by Sorafenib n=2 Participants Radiation therapy, stereotactic body radiation therapy followed by Sorafenib Sorafenib: Nexavar in bottles of 120 tables Stereotactic Body Radiotherapy (SBRT): SBRT
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by ADC (Apparent Diffusion Coefficient). at baseline	1.29 milimeters^2/sec Standard Deviation 0.09
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by ADC (Apparent Diffusion Coefficient). at 4 weeks after baseline	1.55 milimeters^2/sec Standard Deviation 0.13
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by ADC (Apparent Diffusion Coefficient). at 10 weeks after baseline	1.65 milimeters^2/sec Standard Deviation 0.18

Adverse Events

Radiation Followed by Sorafenib

Serious events: 1 serious events

Other events: 1 other events

Deaths: 3 deaths

Serious adverse events

Measure	Radiation Followed by Sorafenib n=5 participants at risk Radiation therapy, stereotactic body radiation therapy followed by Sorafenib Sorafenib: Nexavar in bottles of 120 tables Stereotactic Body Radiotherapy (SBRT): SBRT
Hepatobiliary disorders Hyperbilirubinemia	20.0% 1/5 • Number of events 1 • Baseline and 3 years

Other adverse events

Measure	Radiation Followed by Sorafenib n=5 participants at risk Radiation therapy, stereotactic body radiation therapy followed by Sorafenib Sorafenib: Nexavar in bottles of 120 tables Stereotactic Body Radiotherapy (SBRT): SBRT
General disorders Nausea	20.0% 1/5 • Number of events 1 • Baseline and 3 years
General disorders Fatigue	20.0% 1/5 • Number of events 1 • Baseline and 3 years

Additional Information

Dr. Kimberly Keene

University of Alabama at Birmingham

Phone: 2-5-934-5670

Email: kkeene@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place