Temozolomide and Radiation Therapy in Treating Patients With Gliomas

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. Identifier: NCT00114140
Recruitment Status : Active, not recruiting
First Posted : June 14, 2005
Results First Posted : November 6, 2017
Last Update Posted : December 8, 2017
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

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

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
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] 
Protocol Violation                7 
[1] Subjects with data available for the primary analysis are considered to have completed the study.

  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.
Eligible patients

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

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

  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

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

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

Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00114140     History of Changes
Other Study ID Numbers: RTOG 0424
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