Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Radiation Therapy and Temozolomide Followed by Temozolomide Plus Sorafenib for Glioblastoma Multiforme

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00544817
First received: October 15, 2007
Last updated: November 15, 2012
Last verified: November 2012
Results First Received: November 15, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glioblastoma Multiforme
Interventions: Radiation: Radiation Therapy
Drug: Temozolomide
Drug: Sorafenib

  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
Between April 2007 and July 2008, 47 patients were enrolled

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
Combination Therapy

In the combined modality portion of the study, patients were administered:

Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily

Patients took a four week break before beginning follow-up systemic therapy:

Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months


Participant Flow for 3 periods

Period 1:   Combined Modality
    Combination Therapy  
STARTED     47  
COMPLETED     40  
NOT COMPLETED     7  
Lack of Efficacy                 2  
Worsening Neurologic Symptoms                 2  
Adverse Event                 2  
Intercurrent Illness - Pneumonia                 1  

Period 2:   No Treatment Interval
    Combination Therapy  
STARTED     40  
COMPLETED     28  
NOT COMPLETED     12  
Lack of Efficacy                 8  
Physician Decision                 3  
Adverse Event                 1  

Period 3:   Follow-up Systemic Therapy
    Combination Therapy  
STARTED     28  
COMPLETED     9  
NOT COMPLETED     19  
Lack of Efficacy                 15  
Physician Decision                 3  
Intercurrent Illness - Pneumonia                 1  



  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
Combination Therapy

In the combined modality portion of the study, patients were administered:

Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily

Patients took a four week break before beginning follow-up systemic therapy:

Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months


Baseline Measures
    Combination Therapy  
Number of Participants  
[units: participants]
  47  
Age  
[units: years]
Median ( Full Range )
  54  
  ( 28 to 79 )  
Gender  
[units: participants]
 
Female     16  
Male     31  
Region of Enrollment  
[units: participants]
 
United States     47  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival.   [ Time Frame: 18 months ]

2.  Secondary:   Overall Survival   [ Time Frame: 18 months ]

3.  Secondary:   Objective Response Rate   [ Time Frame: 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 877-691-7274
e-mail: ASKSARAH@scresearch.net


Publications of Results:

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00544817     History of Changes
Other Study ID Numbers: SCRI CNS 09
Study First Received: October 15, 2007
Results First Received: November 15, 2012
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board