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Radiation Therapy to Treat Musculoskeletal Tumors

This study is currently recruiting participants.
Study NCT00186992.   Last updated on December 2, 2008.   Information provided by St. Jude Children's Research Hospital

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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.

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 ]
Secondary Outcome Measure 
Condition  Sarcoma, Ewing's
Rhabdomyosarcoma
Soft Tissue Sarcoma
Musculoskeletal Tumors
Intervention  Procedure: Delivery of conformal limited margin radiotherapy
MEDLINE PMIDs 18234441,   17145403,   17097831
Links St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  210
Start Date  January 2003
Completion Date December 2010
Eligibility Criteria 

Inclusion Criteria:

  • Age less than or equal to 25 years
  • Musculoskeletal tumor involving the primary site of origin requiring definitive, pre-operative or post-operative irradiation to that primary site
Gender Both
Ages up to 25 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Matthew Krasin, MD     866-278-5833     info@stjude.org    
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 
Principal Investigator:     Matthew Krasin, MD     St. Jude Children's Research Hospital    
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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