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| Sponsored by: |
St. Jude Children's Research Hospital |
|---|---|
| Information provided by: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00187226 |
Purpose
The purpose of the study is to determine if Image-Guided Radiation Therapy has less side effects than standard radiation therapy, without affecting the success of radiation treatment and to examine the effect of radiation on learning, thinking, hearing, and the production of hormones.
| Condition | Intervention | Phase |
|---|---|---|
|
Central Nervous System Tumors Brain Tumors |
Procedure: Radiation Therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | A Phase II Study of Image-Guided Radiation Therapy for Pediatric CNS Tumors and Quantification of Radiation-Related CNS Effects |
| Estimated Enrollment: | 300 |
| Study Start Date: | June 1997 |
| Estimated Study Completion Date: | January 2019 |
| Estimated Primary Completion Date: | January 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
The sequencing of evaluation and treatment will be standardized according to the treatment table once the patient has been directed to receive radiation therapy.
|
Procedure: Radiation Therapy
External Beam Radiation Therapy: 54 Gy administered at 1.8 Gy per day
|
Radiation therapy is commonly used to treat low-grade gliomas, low-grade non-glial neoplasms and high grade gliomas. The ability of the therapy to control disease varies depending on the location of the tumor. Children who receive Image-Guided Radiation Therapy (IGRT) for brain tumors are currently being followed for a period of ten years following treatment to evaluate tumor response to treatment. This study will collect information before and during long term follow-up (10 years) for patients who receive Image-Guided Radiation Therapy as treatment for brain tumors. Information about long term control of the disease and the effects of the treatment on patients' functional abilities will be made available by studying the patient for a longer period of time.
Eligibility| Ages Eligible for Study: | 8 Months to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Thomas E. Merchant, D.O., Ph.D. | 1-866-278-5833 | info@stjude.org |
| United States, Tennessee | |
| St.Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: Thomas E. Merchant, D.O., Ph.D 866-278-5833 info@stjude.org | |
| Principal Investigator: Thomas E. Merchant, D.O., Ph.D. | |
| Principal Investigator: | Thomas E. Merchant, D.O., Ph.D. | St. Jude Children's Research Hospital |
More Information
| Responsible Party: | St. Jude Children's Research Hospital ( Thomas E. Merchant, DO, PhD / Study Principal Investigator ) |
| Study ID Numbers: | RT1 |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00187226 |
| Health Authority: | United States: Institutional Review Board |
|
Brain neoplasm Brain cancer Neoplasm intracranial |
|
Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |
|
Neoplasms Neoplasms by Site Nervous System Diseases |
