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Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma

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.
ClinicalTrials.gov Identifier: NCT00895622
Recruitment Status : Active, not recruiting
First Posted : May 8, 2009
Results First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Brain and Central Nervous System Tumors
Interventions: Radiation: 54 Gy radiotherapy
Radiation: 60 Gy radiotherapy

  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
Two hundred forty-four patients registered for the first step registration which consisted of central pathology review confirmation of histology. One hundred seventy-eight continued on to the second step registration.

Reporting Groups
  Description
Low Risk No treatment given
Intermidiate Risk 54 Gy radiotherapy
High Risk 60 Gy radiotherapy

Participant Flow:   Overall Study
    Low Risk   Intermidiate Risk   High Risk
STARTED   65   56   57 
COMPLETED   60   52   53 
NOT COMPLETED   5   4   4 
Protocol Violation                5                4                4 



  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.
All eligible patients

Reporting Groups
  Description
Low Risk No treatment given
Intermidiate Risk 54 Gy radiotherapy
High Risk 60 Gy radiotherapy
Total Total of all reporting groups

Baseline Measures
   Low Risk   Intermidiate Risk   High Risk   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   52   53   165 
Age 
[Units: Years]
Median (Full Range)
 56 
 (31 to 79) 
 53 
 (18 to 73) 
 62 
 (19 to 94) 
 56 
 (18 to 94) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      48  80.0%      32  61.5%      28  52.8%      108  65.5% 
Male      12  20.0%      20  38.5%      25  47.2%      57  34.5% 


  Outcome Measures

1.  Primary:   Progression-free Survival Rate at 3 Years   [ Time Frame: From registration to 3 years ]

2.  Secondary:   Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia]   [ Time Frame: From start of radiation to 90 days. ]

3.  Secondary:   Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia]   [ Time Frame: Ninety-one days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 6.3 years. ]

4.  Secondary:   Overall Survival Rate at 3 Years   [ Time Frame: From registration to 3 years ]

5.  Secondary:   Progression-free Survival Rate at 3 Years (Kaplan-Meier Method)   [ Time Frame: From registration to 3 years ]

6.  Secondary:   Concordance Between Central and Parent Institution Histopathologic Grading/Subtyping   [ Time Frame: Baseline ]

7.  Secondary:   MRI Imaging Predictors as Assessed by Central Neuroradiology Review at Diagnosis, at Any Failure, and at 3 Years   [ Time Frame: From registration to 3 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  

8.  Secondary:   Adherence to Protocol-specific Target and Normal Tissue Radiotherapy Parameters   [ Time Frame: After treatment delivery ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  

9.  Secondary:   Molecular Correlative Studies   [ Time Frame: From registration to 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Histopathologic Correlates of PFS Including Light Microscopy, Immunohistochemical Analysis, and Microarray Analysis   [ Time Frame: From registration to 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


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

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00895622     History of Changes
Other Study ID Numbers: RTOG-0539
CDR0000641815
First Submitted: May 7, 2009
First Posted: May 8, 2009
Results First Submitted: December 18, 2017
Results First Posted: January 19, 2018
Last Update Posted: January 19, 2018