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

This study has been 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.)
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
Dr. Kimberly Keene, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01005875
First received: October 30, 2009
Last updated: May 12, 2014
Last verified: May 2014
Results First Received: April 9, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hepatocellular Carcinoma
Liver Cancer
Interventions: Drug: Sorafenib
Radiation: Stereotactic Body Radiotherapy (SBRT)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Radiation Followed by Sorafenib  
STARTED     5  
COMPLETED     2  
NOT COMPLETED     3  
Death                 3  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Baseline Measures
    Radiation Followed by Sorafenib  
Number of Participants  
[units: participants]
  5  
Age  
[units: years]
Mean ( Full Range )
  60  
  ( 50 to 77 )  
Gender  
[units: participants]
 
Female     2  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Determine the Safety and Tolerability of Sequential SBRT and Sorafenib in Patients With Unresectable Hepatocellular Carcinoma   [ Time Frame: between baseline and 3 years ]

2.  Secondary:   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   [ Time Frame: baseline, 4 weeks and 10 weeks ]

3.  Secondary:   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).   [ Time Frame: baseline, 4 weeks and 10 weeks ]

4.  Secondary:   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.   [ Time Frame: baseline, 4 weeks after baseline and 10 weeks post baseline ]

5.  Secondary:   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).   [ Time Frame: baseline, 4 weeks post baseline, 10 weeks post baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was closed due to slow accural and enrolled 5 of the 10 planned patients.


  More Information
  Hide More Information

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
e-mail: kkeene@uab.edu


No publications provided


Responsible Party: Dr. Kimberly Keene, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01005875     History of Changes
Other Study ID Numbers: F090910004
Study First Received: October 30, 2009
Results First Received: April 9, 2014
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board