| September 12, 2005 |
| October 28, 2009 |
| January 2003 |
| December 2010 (final data collection date for 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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- To study the success of radiation to prevent the recurrence of the tumor at its original site.
- To study the effect of radiation on bone growth, muscle development and other soft tissues.
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| Complete list of historical versions of study NCT00186992 on ClinicalTrials.gov Archive Site |
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| Radiation Therapy to Treat Musculoskeletal Tumors |
| Image Guided Radiotherapy for the Treatment of Musculoskeletal Tumors: A Phase II Prospective Evaluation of Radiation-related Treatment Effects |
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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| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
- Sarcoma, Ewing's
- Rhabdomyosarcoma
- Soft Tissue Sarcoma
- Musculoskeletal Tumors
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| Procedure: Delivery of conformal limited margin radiotherapy |
| Other: Eligible patients will be accessioned at the time of irradiation and undergoo a pre-radiotherapy evaluation, treatment planning, image-guided radiotherapy delivery and intra-and post-irradiation evaluations. |
- Hua C, Gray JM, Merchant TE, Kun LE, Krasin MJ. Treatment Planning and Delivery of External Beam Radiotherapy for Pediatric Sarcoma: The St. Jude Children's Research Hospital Experience. Int J Radiat Oncol Biol Phys. 2008 Apr 1;70(5):1598-606. Epub 2008 Jan 30.
- Krasin MJ, Xiong X, Reddick WE, Ogg RJ, Hoffer FA, McCarville B, Kaste SC, Spunt SL, Navid F, Davidoff AM, Zhang L, Kun LE, Merchant TE. A model for quantitative changes in the magnetic resonance parameters of muscle in children after therapeutic irradiation. Magn Reson Imaging. 2006 Dec;24(10):1319-24. Epub 2006 Oct 25.
- Hua C, Shukla HI, Merchant TE, Krasin MJ. Estimating differences in volumetric flat bone growth in pediatric patients by radiation treatment method. Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):552-8. Epub 2006 Nov 9.
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| Recruiting |
| 210 |
| December 2010 |
| December 2010 (final data collection date for primary outcome measure) |
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
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| Both |
| up to 25 Years |
| No |
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| United States |
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| NCT00186992 |
| Matthew Krasin, MD/Principal Investigator, St. Jude Children's Research Hospital |
| RTSARC |
| St. Jude Children's Research Hospital |
| Lance Armstrong Foundation |
| Principal Investigator: |
Matthew Krasin, MD |
St. Jude Children's Research Hospital |
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| St. Jude Children's Research Hospital |
| October 2009 |
