Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Temozolomide and Radiation Therapy With or Without Cediranib Maleate in Treating Patients With Newly Diagnosed Glioblastoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01062425
First received: February 3, 2010
Last updated: July 28, 2016
Last verified: July 2016
Results First Received: July 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Adult Glioblastoma
Adult Gliosarcoma
Interventions: Radiation: Radiation Therapy
Drug: Cediranib
Other: Placebo
Drug: Temozolomide

  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
After patient registration, sites submitted tissue for central histology and methyltransferase (MGMT) gene methylation evaluation. If tissue was evaluable and a patient continued on study, then treatment arm was assigned. Two hundred sixty-one patients were registered, 103 did not continue to treatment assignment, 158 had treatment assigned.

Reporting Groups
  Description
Placebo, TMZ, and RT Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
Cediranib, TMZ, and RT Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum

Participant Flow:   Overall Study
    Placebo, TMZ, and RT     Cediranib, TMZ, and RT  
STARTED     55     103  
COMPLETED     52 [1]   97 [1]
NOT COMPLETED     3     6  
Protocol Violation                 3                 6  
[1] Randomized eligible subjects 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 randomized and eligible patients.

Reporting Groups
  Description
Placebo, TMZ, and RT Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
Cediranib, TMZ, and RT Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
Total Total of all reporting groups

Baseline Measures
    Placebo, TMZ, and RT     Cediranib, TMZ, and RT     Total  
Number of Participants  
[units: participants]
  52     97     149  
Age  
[units: years]
Median (Full Range)
  59  
  (37 to 82)  
  61  
  (27 to 83)  
  60  
  (27 to 83)  
Gender  
[units: participants]
     
Female     24     44     68  
Male     28     53     81  



  Outcome Measures
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1.  Primary:   6-month Progression-free Survival Rate   [ Time Frame: From randomization to 6 months. ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: From randomization to time of death due to any cause. Patients are followed until death. Analysis occurs after all patients have been potentially followed for six months. ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From randomization to time of first progression or death due to any cause. Patients are followed until death. Analysis occurs after all patients have been potentially followed for six months. ]

4.  Secondary:   Incidence of Grade 3+ Toxicities   [ Time Frame: From randomization to six 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
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  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 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: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01062425     History of Changes
Other Study ID Numbers: NCI-2011-02012
NCI-2011-02012 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000665163
RTOG 0837 ( Other Identifier: NRG Oncology )
RTOG-0837 ( Other Identifier: CTEP )
U10CA180868 ( US NIH Grant/Contract Award Number )
U10CA021661 ( US NIH Grant/Contract Award Number )
Study First Received: February 3, 2010
Results First Received: July 28, 2016
Last Updated: July 28, 2016
Health Authority: United States: Food and Drug Administration