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Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (RTOG 0913)

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ClinicalTrials.gov Identifier: NCT01062399
Recruitment Status : Active, not recruiting
First Posted : February 4, 2010
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Brain and Central Nervous System Tumors
Interventions: Drug: concurrent RAD001 10 mg/day
Drug: concurrent temozolomide
Radiation: Radiation therapy
Drug: concurrent RAD001 2.5 mg/day
Drug: concurrent RAD001 5 mg/day
Drug: post-radiation RAD001 10 mg/day
Drug: post-radiation temozolomide

  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
A total of 279 patients registered at 1st registration for central pathology review of histology confirmation. Among 279 patients, 72 patients did not go beyond 2nd step registration due to insufficient tissue, patient refusal, progression of disease, and other reasons.

Reporting Groups
  Description
Ph I: RT + TMZ + RAD001 2.5 mg/Day Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
Ph I: RT + TMZ + RAD001 5 mg/Day Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
Ph I: RT + TMZ + RAD001 10 mg/Day Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
Ph II: RT + TMZ Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
Ph II: RT + TMZ + RAD001 Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day

Participant Flow:   Overall Study
    Ph I: RT + TMZ + RAD001 2.5 mg/Day   Ph I: RT + TMZ + RAD001 5 mg/Day   Ph I: RT + TMZ + RAD001 10 mg/Day   Ph II: RT + TMZ   Ph II: RT + TMZ + RAD001
STARTED   8   10   8   89   92 
COMPLETED   8 [1]   9   8   83   88 
NOT COMPLETED   0   1   0   6   4 
Protocol Violation                0                1                0                6                4 
[1] Subjects with data available for the primary analyses 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 randomized patients

Reporting Groups
  Description
Ph I: RT + TMZ + RAD001 2.5 mg/Day Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
Ph I: RT + TMZ + RAD001 5 mg/Day Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
Ph I: RT + TMZ + RAD001 10 mg/Day Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
Ph II: RT + TMZ Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
Ph II: RT + TMZ + RAD001 Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
Total Total of all reporting groups

Baseline Measures
   Ph I: RT + TMZ + RAD001 2.5 mg/Day   Ph I: RT + TMZ + RAD001 5 mg/Day   Ph I: RT + TMZ + RAD001 10 mg/Day   Ph II: RT + TMZ   Ph II: RT + TMZ + RAD001   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   9   8   83   88   196 
Age 
[Units: Years]
Median (Full Range)
 58 
 (39 to 72) 
 57 
 (39 to 69) 
 57 
 (31 to 73) 
 57 
 (23 to 79) 
 61 
 (25 to 82) 
 59 
 (23 to 82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      4  50.0%      1  11.1%      6  75.0%      37  44.6%      32  36.4%      80  40.8% 
Male      4  50.0%      8  88.9%      2  25.0%      46  55.4%      56  63.6%      116  59.2% 


  Outcome Measures

1.  Primary:   Phase I: Number of Patients With Dose-limiting Toxicity (DLT)   [ Time Frame: From start of treatment to eight weeks. ]

2.  Primary:   Phase II: Progression-free Survival (PFS)   [ Time Frame: Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months. ]

3.  Secondary:   Phase II: Overall Survival (OS)   [ Time Frame: Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months. ]

4.  Secondary:   Phase I: Distribution of Worst Adverse Event Grade   [ Time Frame: Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months. ]

5.  Secondary:   Phase II: Distribution of Worst Adverse Event Grade   [ Time Frame: Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 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
No text entered.


  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: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org


Publications of Results:

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01062399     History of Changes
Other Study ID Numbers: RTOG 0913
RTOG-0913
CDR0000664302
NCI-2011-00885 ( Registry Identifier: CTRP: (Clinical Trials Reporting Office) )
First Submitted: February 3, 2010
First Posted: February 4, 2010
Results First Submitted: November 13, 2017
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018