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Trial record 1 of 1 for:    n0574
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Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00377156
First Posted: September 15, 2006
Last Update Posted: August 24, 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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
Results First Submitted: February 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Breast Cancer
Cognitive/Functional Effects
Lung Cancer
Metastatic Cancer
Prostate Cancer
Interventions: Radiation: radiation therapy
Radiation: stereotactic radiosurgery

  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
At 34 institutions in North America, patients with 1 to 3 brain metastases were randomized to receive SRS or SRS plus WBRT between February 2002 and December 2013. 70 patients accrued by ACOSOG Z0300 were included in the power calculation and also included for this study.

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
Arm I (SRS) Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
Arm II (SRS+WBRT)

Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >

> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS.


Participant Flow:   Overall Study
    Arm I (SRS)   Arm II (SRS+WBRT)
STARTED   111   102 
COMPLETED   63   48 
NOT COMPLETED   48   54 
Death                23                19 
Withdrawal by Subject                16                24 
Had follow-up <90 d                3                6 
Cancellation                1                0 
Refused testing                0                1 
Ineligible                0                1 
Disability or language problem                0                1 
Other                5                2 



  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.
No text entered.

Reporting Groups
  Description
Arm I (SRS) Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
Arm II (SRS+WBRT)

Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >

> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS.

Total Total of all reporting groups

Baseline Measures
   Arm I (SRS)   Arm II (SRS+WBRT)   Total 
Overall Participants Analyzed 
[Units: Participants]
 111   102   213 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.8  (10.4)   61.4  (10.6)   60.6  (10.5) 
Age, Customized 
[Units: Participants]
Count of Participants
     
18 to 59   53   44   97 
>= 60   58   58   116 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      57  51.4%      47  46.1%      104  48.8% 
Male      54  48.6%      55  53.9%      109  51.2% 
Region of Enrollment 
[Units: Participants]
     
Canada   23   22   45 
United States   88   80   168 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months   [ Time Frame: 3 months post radiosurgery ]

2.  Secondary:   Number of Participants With Local and Distant Tumor Control up to 3 Months   [ Time Frame: Up to 3 months ]

3.  Secondary:   Overall Quality of Life, as Measured by Mean Change From Baseline [3 Month]   [ Time Frame: From Baseline to 3-Month Evaluation ]

4.  Secondary:   Long-Term Neurocognitive Status (Long-Term Cognitive Status), as Measured by Percentage of Long-term Survivors With Cognitive Deterioration at 12 Months   [ Time Frame: From baseline to 12 months ]

5.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Paul Brown, M.D.
Organization: Mayo Clinic
phone: 507-538-0948
e-mail: Brown.Paul@mayo.edu


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

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00377156     History of Changes
Other Study ID Numbers: N0574
NCCTG-N0574
ACOSOG-N0574
CDR0000499633 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2009-00653 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted: September 13, 2006
First Posted: September 15, 2006
Results First Submitted: February 27, 2017
Results First Posted: August 24, 2017
Last Update Posted: August 24, 2017