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Memantine in Preventing Side Effects in Patients Undergoing Whole-Brain Radiation Therapy for Brain Metastases From Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00566852
First Posted: December 4, 2007
Last Update Posted: August 21, 2017
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.
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
Results First Submitted: April 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions: Cognitive/Functional Effects
Metastatic Cancer
Neurotoxicity
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: Memantine
Other: Placebo
Radiation: Whole brain radiation therapy

  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
WBRT+Memantine Whole brain radiation therapy (WBRT) and memantine
WBRT+Placebo Whole brain radiation therapy (WBRT) and placebo

Participant Flow:   Overall Study
    WBRT+Memantine   WBRT+Placebo
STARTED   278   276 
COMPLETED   71 [1]   78 [1] 
NOT COMPLETED   207   198 
Protocol Violation                22                24 
Death                95                78 
Withdrawal by Subject                30                25 
Patient refusal                37                37 
Not tested due to disability                6                12 
Missing reason not specified                1                2 
Missing reason not reported                16                20 
[1] Subjects with data available for 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 randomized eligible patients.

Reporting Groups
  Description
WBRT+Memantine Whole brain radiation therapy (WBRT) and memantine
WBRT+Placebo Whole brain radiation therapy (WBRT) and placebo
Total Total of all reporting groups

Baseline Measures
   WBRT+Memantine   WBRT+Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 256   252   508 
Age 
[Units: Years]
Median (Full Range)
 60 
 (31 to 84) 
 59 
 (29 to 86) 
 59 
 (29 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      141  55.1%      145  57.5%      286  56.3% 
Male      115  44.9%      107  42.5%      222  43.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 24 Weeks   [ Time Frame: Baseline and 24 weeks from the start of drug treatment ]

2.  Secondary:   Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 8, 16, and 52 Weeks   [ Time Frame: Baseline, 8, 16, and 52 weeks from the start of drug treatment ]

3.  Secondary:   Median Time to Neurocognitive Failure   [ Time Frame: Baseline to 12 months from the start of drug treatment ]

4.  Secondary:   Change in Functional Assessment of Cancer Therapy With Brain Subscale (FACT-Br) at 24 Weeks   [ Time Frame: Baseline and 24 weeks from start of treatment ]

5.  Secondary:   Median Progression-free Survival Time   [ Time Frame: From randomization to date of progression, death or last follow-up. Analysis occurs at the same time as the primary outcome. Patients are followed until death and all follow-up collected at time of analysis is used. ]

6.  Secondary:   Overall Survival   [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs at the same time as the primary outcome. Patients are followed until death and all follow-up collected at time of analysis is used. ]


  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
Given the poor compliance of the HVLT-R at 24 weeks, there was only 35% statistical power to detect the hypothesized effect size. Please see linked manuscript.


  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


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

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00566852     History of Changes
Other Study ID Numbers: RTOG-0614
CDR0000577872
NCI-2009-00735 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: December 1, 2007
First Posted: December 4, 2007
Results First Submitted: April 19, 2016
Results First Posted: July 21, 2017
Last Update Posted: August 21, 2017