A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects
This study has been completed.
Sponsor:
St. Jude Children's Research Hospital
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
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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
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
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
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided by St. Jude Children's Research Hospital
Publications automatically indexed to this study:
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| 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. |
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
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 |