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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;   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
No text entered.

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.
No text entered.

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 
Overall Participants Analyzed 
[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


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

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