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| Descriptive Information Fields | |||||
| Brief Title † | Radiation Therapy to Treat Musculoskeletal Tumors | ||||
| Official Title † | Image Guided Radiotherapy for the Treatment of Musculoskeletal Tumors: A Phase II Prospective Evaluation of Radiation-Related Treatment Effects | ||||
| Brief Summary | Researchers at St. Jude Children's Research Hospital are looking for more effective ways to deliver radiation therapy to pediatric tumors of the bone and soft tissues. The goal of the study is to improve local control of musculoskeletal tumors with image-guided radiation therapy (IGRT) while minimizing radiation related side effects. IGRT uses computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) images to precisely define tumor location and to carefully plan radiation treatment. This approach allows doctors to deliver highly conformal radiation therapy to the tumor while protecting nearby healthy normal tissues. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | To study the success of radiation to prevent the recurrence of the tumor at its original site [ Time Frame: 5 years ] [ Designated as safety issue: No ] To study the effect of radiation on bone growth, muscle development and other soft tissues [ Time Frame: 5 years ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Sarcoma, Ewing's Rhabdomyosarcoma Soft Tissue Sarcoma Musculoskeletal Tumors |
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| Intervention † | Procedure: Delivery of conformal limited margin radiotherapy | ||||
| MEDLINE PMIDs | 18234441, 17145403, 17097831 | ||||
| Links | St. Jude Children's Research Hospital  |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 210 | ||||
| Start Date † | January 2003 | ||||
| Completion Date | December 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 25 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00186992 | ||||
| Organization ID | RTSARC | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | St. Jude Children's Research Hospital | ||||
| Collaborators †† | Lance Armstrong Foundation | ||||
| Investigators † |
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| Information Provided By | St. Jude Children's Research Hospital | ||||
| Verification Date | December 2008 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | December 2, 2008 | ||||
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