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Temozolomide (TMZ) and Radiation Therapy (RT) With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00884741
First received: April 18, 2009
Last updated: November 14, 2016
Last verified: November 2016
Results First Received: December 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Cognitive Side Effects of Cancer Therapy
Interventions: Radiation: Radiation therapy pre-randomization
Biological: Bevacizumab
Drug: Placebo
Drug: Temozolomide pre-randomization
Drug: Temozolomide post-randomization
Radiation: Radiation therapy post-randomization

  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
Step 1 Registration No treatment. Central Pathology Tissue Screening to confirm histology and adequacy of tissue for MGMT analysis and molecular profile. Tumor tissue must be received and central review confirmation completed before STEP 2 registration can occur.
Step 2 Registration: Pre-Randomization TMZ+RT Temozolomide pre-randomization, radiation therapy pre-randomization
Randomized Arm 1: TMZ+RT + Placebo Temozolomide post-randomization,Radiation therapy post-randomization, placebo
Randomized Arm 2: TMZ+RT + Bevacizumab Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab

Participant Flow for 3 periods

Period 1:   Step 1 Registration: Tissue Screening
    Step 1 Registration   Step 2 Registration: Pre-Randomization TMZ+RT   Randomized Arm 1: TMZ+RT + Placebo   Randomized Arm 2: TMZ+RT + Bevacizumab
STARTED   978   0   0   0 
COMPLETED   666   0   0   0 
NOT COMPLETED   312   0   0   0 
Protocol Violation                157                0                0                0 
Death                3                0                0                0 
Physician Decision                3                0                0                0 
Insufficient tissue                105                0                0                0 
Disease progression                12                0                0                0 
Patient refusal                32                0                0                0 

Period 2:   Step 2 Registration: Tissue Analysis
    Step 1 Registration   Step 2 Registration: Pre-Randomization TMZ+RT   Randomized Arm 1: TMZ+RT + Placebo   Randomized Arm 2: TMZ+RT + Bevacizumab
STARTED   0 [1]   666 [2]   0   0 
COMPLETED   0   637   0   0 
NOT COMPLETED   0   29   0   0 
Protocol Violation                0                15                0                0 
Death                0                1                0                0 
Adverse Event                0                2                0                0 
Patient refusal                0                7                0                0 
Disease Progression                0                4                0                0 
[1] Step 1 Registration Arm goes to Step 2 Registration Arm
[2] These patients completed the previous period on the Step 1 Registration arm.

Period 3:   Randomization
    Step 1 Registration   Step 2 Registration: Pre-Randomization TMZ+RT   Randomized Arm 1: TMZ+RT + Placebo   Randomized Arm 2: TMZ+RT + Bevacizumab
STARTED   0   0 [1]   317 [2]   320 [2] 
COMPLETED   0   0   309 [3]   312 [3] 
NOT COMPLETED   0   0   8   8 
Protocol Violation                0                0                8                8 
[1] Step 2 Registration Arm goes to a randomized arm.
[2] These patients completed the previous period on the Step 2 Registration arm.
[3] Patients 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.
All eligible patients. Note that the Pre-Randomization TMZ+RT arm only includes eligible patients that did not continue to randomization.

Reporting Groups
  Description
Pre-Randomization TMZ+RT Temozolomide pre-randomization, radiation therapy pre-randomization. Note that for the purpose of this table, this arm only includes patients that did not continue to randomization.
Randomized Arm 1: TMZ+RT + Placebo Temozolomide post-randomization,Radiation therapy post-randomization, placebo
Randomized Arm 2: TMZ+RT + Bevacizumab Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
Total Total of all reporting groups

Baseline Measures
   Pre-Randomization TMZ+RT   Randomized Arm 1: TMZ+RT + Placebo   Randomized Arm 2: TMZ+RT + Bevacizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   309   312   650 
Age 
[Units: Years]
Median (Full Range)
 58 
 (25 to 75) 
 57 
 (19 to 82) 
 59 
 (21 to 82) 
 58 
 (19 to 82) 
Gender 
[Units: Participants]
Count of Participants
       
Female      11  37.9%      115  37.2%      134  42.9%      260  40.0% 
Male      18  62.1%      194  62.8%      178  57.1%      390  60.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported. ]

2.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported. ]

3.  Secondary:   Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0   [ Time Frame: Up to 30 days ]

4.  Other Pre-specified:   Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)   [ Time Frame: Analysis can occur at or after time of primary outcome measure analysis. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Other Pre-specified:   Neurocognitive Function Measured by the Hopkins Verbal Learning Test-Revised(HVLT-R), Trail Making Test Part A, Trail Making Test Part B, Controlled Oral Word Association Test (COWAT)   [ Time Frame: Analysis can occur at or after time of primary outcome measure analysis. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  More Information
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00884741     History of Changes
Other Study ID Numbers: NCI-2009-01670
NCI-2009-01670 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RTOG-0825
CDR0000640428
RTOG 0825 ( Other Identifier: NRG Oncology )
RTOG-0825 ( Other Identifier: CTEP )
U10CA180868 ( US NIH Grant/Contract Award Number )
U10CA021661 ( US NIH Grant/Contract Award Number )
Study First Received: April 18, 2009
Results First Received: December 18, 2015
Last Updated: November 14, 2016
Health Authority: United States: Food and Drug Administration