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Temozolomide and Radiation Therapy in Treating Patients With Gliomas

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00114140
First Posted: June 14, 2005
Last Update Posted: December 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
Results First Submitted: January 17, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Brain and Central Nervous System Tumors
Interventions: Drug: Temozolomide
Radiation: Radiation therapy

  Participant Flow
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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
Temozolomide + Radiation Therapy (RT) Daily temozolomide plus concurrent radiotherapy followed by temozolomide

Participant Flow:   Overall Study
    Temozolomide + Radiation Therapy (RT)
STARTED   136 
COMPLETED   129 [1] 
NOT COMPLETED   7 
Protocol Violation                7 
[1] Subjects with data available for the primary analysis are considered to have completed the study.



  Baseline Characteristics
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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.
Eligible patients

Reporting Groups
  Description
Temozolomide + Radiation Therapy (RT) Daily temozolomide plus concurrent radiotherapy followed by temozolomide

Baseline Measures
   Temozolomide + Radiation Therapy (RT) 
Overall Participants Analyzed 
[Units: Participants]
 129 
Age 
[Units: Years]
Median (Full Range)
 49 
 (20 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      54  41.9% 
Male      75  58.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival Rate at 3 Years   [ Time Frame: Registration to 3 years ]

2.  Primary:   Progression-free Survival   [ Time Frame: From registration to last follow-up, up to 7.1 years. Analysis occurs after all patients have been on study for at least 3 years. ]

3.  Primary:   Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status   [ Time Frame: Registration to 3 years ]

4.  Primary:   Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR)   [ Time Frame: Baseline, 6 months, and 12 months. ]

5.  Primary:   Neurocognitive Function   [ Time Frame: Baseline, 6 months, and 12 months. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Quality of life endpoint was added via an amendment while study was in progress.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org



Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00114140     History of Changes
Other Study ID Numbers: RTOG 0424
CDR0000434849
NCI-2009-00723 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: June 13, 2005
First Posted: June 14, 2005
Results First Submitted: January 17, 2017
Results First Posted: November 6, 2017
Last Update Posted: December 8, 2017