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Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma (RAD 0901)

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ClinicalTrials.gov Identifier: NCT01005875
Recruitment Status : Terminated (Sponsor(Bayer)did not wish to continue with study due to slow accrual. Therefore, there is insufficient data and will not be any study results/outcomes.)
First Posted : November 2, 2009
Results First Posted : June 11, 2014
Last Update Posted : May 10, 2017
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
Dr. Kimberly Keene, University of Alabama at Birmingham

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatocellular Carcinoma
Liver Cancer
Interventions Drug: Sorafenib
Radiation: Stereotactic Body Radiotherapy (SBRT)
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiation Followed by Sorafenib
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Radiation therapy, stereotactic body radiation therapy followed by Sorafenib

Sorafenib: Nexavar in bottles of 120 tables

Stereotactic Body Radiotherapy (SBRT): SBRT

Period Title: Overall Study
Started 5
Completed 2
Not Completed 3
Reason Not Completed
Death             3
Arm/Group Title Radiation Followed by Sorafenib
Hide Arm/Group Description

Radiation therapy, stereotactic body radiation therapy followed by Sorafenib

Sorafenib: Nexavar in bottles of 120 tables

Stereotactic Body Radiotherapy (SBRT): SBRT

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
60
(50 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Determine the Safety and Tolerability of Sequential SBRT and Sorafenib in Patients With Unresectable Hepatocellular Carcinoma
Hide Description Number of subjects experiencing a Grade 5 toxicity related to SBRT and sorafenib
Time Frame between baseline and 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation Followed by Sorafenib
Hide Arm/Group Description:

Radiation therapy, stereotactic body radiation therapy followed by Sorafenib

Sorafenib: Nexavar in bottles of 120 tables

Stereotactic Body Radiotherapy (SBRT): SBRT

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
2
2.Secondary Outcome
Title 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
Hide Description mean tumor volume at baseline, 4 weeks and 10 weeks after start of treatment
Time Frame baseline, 4 weeks and 10 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation Followed by Sorafenib
Hide Arm/Group Description:

Radiation therapy, stereotactic body radiation therapy followed by Sorafenib

Sorafenib: Nexavar in bottles of 120 tables

Stereotactic Body Radiotherapy (SBRT): SBRT

Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: centimeters^3
at baseline 98  (71)
at 4 weeks after baseline 65  (42)
at 10 weeks after baseline 22  (8)
3.Secondary Outcome
Title 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).
Hide Description The initial mean Ktrans at baseline, 4 weeks and 10 week. K trans is used to describe the uptake of gadolinium contrast in tissue.
Time Frame baseline, 4 weeks and 10 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation Followed by Sorafenib
Hide Arm/Group Description:

Radiation therapy, stereotactic body radiation therapy followed by Sorafenib

Sorafenib: Nexavar in bottles of 120 tables

Stereotactic Body Radiotherapy (SBRT): SBRT

Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: min^ -1
at baseline 0.022  (0.009)
at 4 weeks after baseline 0.017  (0.009)
at 10 weeks after baseline 0.014  (0.006)
4.Secondary Outcome
Title 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.
Hide Description The Kep as measures by MRI at baseline, 4 weeks after baseline, and 10 weeks after baseline.
Time Frame baseline, 4 weeks after baseline and 10 weeks post baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation Followed by Sorafenib
Hide Arm/Group Description:

Radiation therapy, stereotactic body radiation therapy followed by Sorafenib

Sorafenib: Nexavar in bottles of 120 tables

Stereotactic Body Radiotherapy (SBRT): SBRT

Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: Min^ -1
at baseline 0.062  (0.018)
at 4 weeks after baseline 0.053  (0.013)
at 10 weeks after baseline 0.050  (0.014)
5.Secondary Outcome
Title 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).
Hide Description 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.
Time Frame baseline, 4 weeks post baseline, 10 weeks post baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation Followed by Sorafenib
Hide Arm/Group Description:

Radiation therapy, stereotactic body radiation therapy followed by Sorafenib

Sorafenib: Nexavar in bottles of 120 tables

Stereotactic Body Radiotherapy (SBRT): SBRT

Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: milimeters^2/sec
at baseline 1.29  (0.09)
at 4 weeks after baseline 1.55  (0.13)
at 10 weeks after baseline 1.65  (0.18)
Time Frame Baseline and 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radiation Followed by Sorafenib
Hide Arm/Group Description

Radiation therapy, stereotactic body radiation therapy followed by Sorafenib

Sorafenib: Nexavar in bottles of 120 tables

Stereotactic Body Radiotherapy (SBRT): SBRT

All-Cause Mortality
Radiation Followed by Sorafenib
Affected / at Risk (%)
Total   3/5 (60.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Radiation Followed by Sorafenib
Affected / at Risk (%) # Events
Total   1/5 (20.00%)    
Hepatobiliary disorders   
Hyperbilirubinemia   1/5 (20.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Radiation Followed by Sorafenib
Affected / at Risk (%) # Events
Total   1/5 (20.00%)    
General disorders   
Nausea   1/5 (20.00%)  1
Fatigue   1/5 (20.00%)  1
Indicates events were collected by systematic assessment
The study was closed due to slow accural and enrolled 5 of the 10 planned patients.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Kimberly Keene
Organization: University of Alabama at Birmingham
Phone: 2-5-934-5670
Responsible Party: Dr. Kimberly Keene, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01005875     History of Changes
Other Study ID Numbers: F090910004
First Submitted: October 30, 2009
First Posted: November 2, 2009
Results First Submitted: April 9, 2014
Results First Posted: June 11, 2014
Last Update Posted: May 10, 2017