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The purpose of the study was to determine if treating a limited volume of normal tissue surrounding the tumor or tumor bed using conformal radiation therapy would achieve similar rates of disease control compared to standard radiation therapy. The study was also conducted to examine the effect of irradiation on neurological, endocrine and cognitive function.
Radiation therapy is commonly used to treat a variety of brain tumors in children including ependymoma, craniopharyngioma and low- and high-grade glioma. The ability of the therapy to control brain tumors in children is known to depend on the tumor type, extent of resection and other clinical factors. Children who received radiation therapy on this study were evaluated for treatment failure at 12 months. In addition to the primary objective, the study was designed to explore the association between radiation dose and volume and a variety of neurological, endocrine and cognitive deficits up to 5 years after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratum 1 | Other | Ependymoma, craniopharyngioma, low-grade glioma |
|
| Stratum 2 | Other | High-grade glioma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Procedure | External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Tumor Control | Local tumor control was determined by Magnetic Resonance Imaging (MRI) of the brain and spine performed after radiation therapy. Imaging studies were performed every 3-4 months during the first three years and then every 6 months through five years. Imaging studies demonstrating tumor progression were electronically registered to the imaging data used to plan therapy. Local failure included tumor progression within the volume that received the prescribed dose of irradiation. | 12 months after the enrollment of the last therapeutic patient |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas E. Merchant, D.O., Ph.D. | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23245284 | Derived | Netson KL, Conklin HM, Wu S, Xiong X, Merchant TE. Longitudinal investigation of adaptive functioning following conformal irradiation for pediatric craniopharyngioma and low-grade glioma. Int J Radiat Oncol Biol Phys. 2013 Apr 1;85(5):1301-6. doi: 10.1016/j.ijrobp.2012.10.031. Epub 2012 Dec 11. |
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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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.
202 patients correspond to the initial number of patients enrolled prior to the amendment which increased accrual 361
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| ID | Title | Description |
|---|---|---|
| FG000 | 1cm Clinical Target Volume Margin - Ependymoma | Patients with Ependymoma in the 1cm clinical target volume margin group. |
| FG001 | 1cm Clinical Target Volume Margin - Low-grade Glioma | Patients with Low-grade Glioma in the 1cm clinical target volume margin group. |
| FG002 | 1cm Clinical Target Volume Margin - Craniopharyngioma | Patients with Craniopharyngioma in the 1cm clinical target volume margin group. |
| FG003 | 1cm Clinical Target Volume Margin - Other | Remaining patients in the 1cm clinical target volume margin group. |
| FG004 | 2cm Clinical Target Volume Margin - High-grade Glioma | Patients with High-grade glioma in the 2cm clinical target volume margin group. |
| FG005 | 2cm Clinical Target Volume Margin - Low-grade Glioma | Patients with Low-grade Glioma in the 2cm clinical target volume margin group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1cm Clinical Target Volume Margin - Ependymoma | Patients with Ependymoma in the 1cm clinical target volume margin group. |
| BG001 | 1cm Clinical Target Volume Margin - Low-grade Glioma |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Tumor Control | Local tumor control was determined by Magnetic Resonance Imaging (MRI) of the brain and spine performed after radiation therapy. Imaging studies were performed every 3-4 months during the first three years and then every 6 months through five years. Imaging studies demonstrating tumor progression were electronically registered to the imaging data used to plan therapy. Local failure included tumor progression within the volume that received the prescribed dose of irradiation. | Patients with Ependymoma, Craniopharyngioma, Low-grade Glioma, and High-grade Glioma were analyzed by diagnosis. | Posted | Log Mean | 95% Confidence Interval | Proportion of patients | 12 months after the enrollment of the last therapeutic patient |
|
Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1cm Clinical Target Volume Margin - Ependymoma | Patients with Ependymoma in the 1cm clinical target volume margin group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CNS Ischemia | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas E. Merchant, DO, PhD | St. Jude Children's Research Hospital | 901-595-3604 | thomas.merchant@stjude.org |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Radiation Therapy | Procedure | External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma. |
|
Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
| BG002 | 1cm Clinical Target Volume Margin - Craniopharyngioma | Patients with Craniopharyngioma in the 1cm clinical target volume margin group. |
| BG003 | 1cm Clinical Target Volume Margin - Other | Remaining patients in the 1cm clinical target volume margin group. |
| BG004 | 2cm Clinical Target Volume Margin - High-grade Glioma | Patients with High-grade glioma in the 2cm clinical target volume margin group. |
| BG005 | 2cm Clinical Target Volume Margin - Low-grade Glioma | Patients with Low-grade Glioma in the 2cm clinical target volume margin group. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 1cm Clinical Target Volume Margin - Low-grade Glioma | Patients with Low-grade Glioma in the 1cm clinical target volume margin group. |
| OG002 | 1cm Clinical Target Volume Margin - Craniopharyngioma | Patients with Craniopharyngioma in the 1cm clinical target volume margin group. |
| OG003 | 1cm Clinical Target Volume Margin - Other | Remaining patients in the 1cm clinical target volume margin group. |
| OG004 | 2cm Clinical Target Volume Margin - High-grade Glioma | Patients with High-grade glioma in the 2cm clinical target volume margin group. |
| OG005 | 2cm Clinical Target Volume Margin - Low-grade Glioma | Patients with Low-grade Glioma in the 2cm clinical target volume margin group. |
|
|
| 1 |
| 88 |
| 9 |
| 88 |
| EG001 | 1cm Clinical Target Volume Margin - Low-grade Glioma | Patients with Low-grade Glioma in the 1cm clinical target volume margin group. | 0 | 49 | 4 | 49 |
| EG002 | 1cm Clinical Target Volume Margin - Craniopharyngioma | Patients with Craniopharyngioma in the 1cm clinical target volume margin group. | 2 | 28 | 0 | 28 |
| EG003 | 1cm Clinical Target Volume Margin - Other | Remaining patients in the 1cm clinical target volume margin group. | 0 | 2 | 0 | 2 |
| EG004 | 2cm Clinical Target Volume Margin - High-grade Glioma | Patients with High-grade glioma in the 2cm clinical target volume margin group. | 1 | 34 | 0 | 34 |
| EG005 | 2cm Clinical Target Volume Margin - Low-grade Glioma | Patients with Low-grade Glioma in the 2cm clinical target volume margin group. | 0 | 1 | 0 | 1 |
| Death | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hemorrhage | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Neuromotor | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |