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Avoiding the Hippocampus During Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01227954
First Posted: October 25, 2010
Last Update Posted: September 27, 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: August 23, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cognitive/Functional Effects
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Intervention: Radiation: intensity-modulated 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
WBRT With Hippocampal Avoidance Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)

Participant Flow:   Overall Study
    WBRT With Hippocampal Avoidance
STARTED   113 
COMPLETED   100 [1] 
NOT COMPLETED   13 
Protocol Violation                6 
No protocol treatment                7 
[1] Eligible subjects available for analysis



  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.
Eligible patients

Reporting Groups
  Description
WBRT With Hippocampal Avoidance Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)

Baseline Measures
   WBRT With Hippocampal Avoidance 
Overall Participants Analyzed 
[Units: Participants]
 100 
Age 
[Units: Years]
Median (Full Range)
 61 
 (28 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      52  52.0% 
Male      48  48.0% 


  Outcome Measures
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1.  Primary:   Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R)   [ Time Frame: Baseline and 4 months from start of treatment ]

2.  Secondary:   Percent Change at 4 Months in Auditory Learning Measured by Cogstate's International Shopping List Test (ISLT)   [ Time Frame: Baseline and 4 months from start of treatment ]

3.  Secondary:   Percent Change at 4 Months in Visual Learning Measured by Cogstate's One Card Learning Test (OCLT)   [ Time Frame: Baseline and 4 months from start of treatment ]

4.  Secondary:   Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)   [ Time Frame: Baseline and 4 months from start of treatment ]

5.  Secondary:   Quality of Life as Measured by the Barthel Index of Activities of Daily Living (ADL)   [ Time Frame: Baseline and 4 months from start of treatment ]

6.  Secondary:   Overall Survival   [ Time Frame: Analysis occurs after all patients have been on study for at least 4 months. (Patients are followed from registration to death or study termination whichever occurs first.) ]

7.  Secondary:   Progression-free Survival   [ Time Frame: Analysis occurs after all patients have been on study for at least 4 months. (Patients are followed from registration to death or study termination whichever occurs first.) ]

8.  Secondary:   The Frequency of Patients With Grade 3 and Higher Adverse Events (AE) Related to Treatment   [ Time Frame: From start of treatment to 12 months from start of treatment ]

9.  Secondary:   ApoE4 Genotype and Other Potentially Predictive Biomarkers of Cognitive Function   [ Time Frame: Baseline and 4 months from start of treatment ]


  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


Publications of Results:

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01227954     History of Changes
Obsolete Identifiers: NCT01366755
Other Study ID Numbers: RTOG-0933
CDR0000687490
First Submitted: October 22, 2010
First Posted: October 25, 2010
Results First Submitted: August 23, 2017
Results First Posted: September 27, 2017
Last Update Posted: September 27, 2017