A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00187226
First received: September 13, 2005
Last updated: August 17, 2012
Last verified: August 2012
Results First Received: May 4, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Central Nervous System Tumors
Brain Tumors
Intervention: Procedure: 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
202 patients were enrolled between July 11, 1997 and January 14, 2003 for the therapeutic phase of the trial. Among those patients, 167 were treated with a 1cm clinical target volume (CTV) margin and 35 were treated with a 2cm CTV margin. Local tumor progression was determined by MR imaging.

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
1cm Clinical Target Volume Margin - Ependymoma Patients with Ependymoma in the 1cm clinical target volume margin group.
1cm Clinical Target Volume Margin - Low-grade Glioma Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
1cm Clinical Target Volume Margin - Craniopharyngioma Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
1cm Clinical Target Volume Margin - Other Remaining patients in the 1cm clinical target volume margin group.
2cm Clinical Target Volume Margin - High-grade Glioma Patients with High-grade glioma in the 2cm clinical target volume margin group.
2cm Clinical Target Volume Margin - Low-grade Glioma Patients with Low-grade Glioma in the 2cm clinical target volume margin group.

Participant Flow:   Overall Study
    1cm Clinical Target Volume Margin - Ependymoma     1cm Clinical Target Volume Margin - Low-grade Glioma     1cm Clinical Target Volume Margin - Craniopharyngioma     1cm Clinical Target Volume Margin - Other     2cm Clinical Target Volume Margin - High-grade Glioma     2cm Clinical Target Volume Margin - Low-grade Glioma  
STARTED     88     49     28     2     34     1  
COMPLETED     88     49     28     2     34     1  
NOT COMPLETED     0     0     0     0     0     0  



  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.
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Reporting Groups
  Description
1cm Clinical Target Volume Margin - Ependymoma Patients with Ependymoma in the 1cm clinical target volume margin group.
1cm Clinical Target Volume Margin - Low-grade Glioma Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
1cm Clinical Target Volume Margin - Craniopharyngioma Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
1cm Clinical Target Volume Margin - Other Remaining patients in the 1cm clinical target volume margin group.
2cm Clinical Target Volume Margin - High-grade Glioma Patients with High-grade glioma in the 2cm clinical target volume margin group.
2cm Clinical Target Volume Margin - Low-grade Glioma Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
Total Total of all reporting groups

Baseline Measures
    1cm Clinical Target Volume Margin - Ependymoma     1cm Clinical Target Volume Margin - Low-grade Glioma     1cm Clinical Target Volume Margin - Craniopharyngioma     1cm Clinical Target Volume Margin - Other     2cm Clinical Target Volume Margin - High-grade Glioma     2cm Clinical Target Volume Margin - Low-grade Glioma     Total  
Number of Participants  
[units: participants]
  88     49     28     2     34     1     202  
Age  
[units: participants]
             
<=18 years     86     48     28     2     26     1     191  
Between 18 and 65 years     2     1     0     0     8     0     11  
>=65 years     0     0     0     0     0     0     0  
Gender  
[units: participants]
             
Female     41     24     16     1     16     0     98  
Male     47     25     12     1     18     1     104  



  Outcome Measures

1.  Primary:   Local Tumor Control   [ Time Frame: 12 months after the enrollment of the last therapeutic patient ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas E. Merchant, DO, PhD
Organization: St. Jude Children's Research Hospital
phone: 901-595-3604
e-mail: thomas.merchant@stjude.org


No publications provided by St. Jude Children's Research Hospital

Publications automatically indexed to this study:

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187226     History of Changes
Other Study ID Numbers: RT1
Study First Received: September 13, 2005
Results First Received: May 4, 2012
Last Updated: August 17, 2012
Health Authority: United States: Institutional Review Board