Radiation Therapy to Treat Musculoskeletal Tumors - Full Text View

Sponsors and Collaborators:	St. Jude Children's Research Hospital Lance Armstrong Foundation
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00186992

Purpose

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.

Condition	Intervention	Phase
Sarcoma, Ewing's Rhabdomyosarcoma Soft Tissue Sarcoma Musculoskeletal Tumors	Procedure: Delivery of conformal limited margin radiotherapy	Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Image Guided Radiotherapy for the Treatment of Musculoskeletal Tumors: A Phase II Prospective Evaluation of Radiation-Related Treatment Effects

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	210
Study Start Date:	January 2003
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 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.	Procedure: Delivery of conformal limited margin radiotherapy Conformal limited image radiotherapy is radiation therapy that targets tumors with a prescribed dose of radiation which allows the surrounding normal tissues to remain basically untreated.

Eligibility

Ages Eligible for Study:	up to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186992

Contacts

Contact: Matthew Krasin, MD

866-278-5833

info@stjude.org

Locations

United States, Tennessee
St. Jude Children's Research Hospital	Recruiting
Memphis, Tennessee, United States, 38105
Contact: Matthew Krasin, MD 866-278-5833 info@stjude.org
Principal Investigator: Matthew Krasin, MD

Sponsors and Collaborators

St. Jude Children's Research Hospital

Lance Armstrong Foundation

Investigators

Principal Investigator:

Matthew Krasin, MD

St. Jude Children's Research Hospital

More Information

St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site

Publications:

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.

Krasin, M J; T.E. Merchant; S.L. Spunt; A.M. Davidoff; F. Navid; S. Wu; X. Xiong; C. Hua; L.E. Kun Early Results of a Prospective Study Delivering Limited Margin Radiotherapy for Pediatric Non-Rhabdo-Soft Tissue Sarcomas (NRSTS) and Aggressive Fibromatoses (AF) International journal of radiation oncology, biology, physics(volume 66 issue 3 Page S112), 2006

Krasin MJ, MD; Xiong X, PhD; Hua C, PhD; Marchese VG, PT, PhD; Cremer L, PT; Zhang L; Spunt SL, MD; Navid F, MD; Merchant TE, DO,PhD. A Model for Changes in Jaw Function in Children Following Therapeutic Irradiation of the Head and Neck presented at The 9th International Conference on Long-term Complications of Treatment of Children and Adolescents for Cancer, 2006

Responsible Party:	St. Jude Children's Research Hospital ( Matthew Krasin, MD/Principal Investigator )
Study ID Numbers:	RTSARC
Study First Received:	September 12, 2005
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00186992
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:

Sarcoma
radiation therapy
Other musculoskeletal tumors

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Sarcoma, Ewing's
Malignant mesenchymal tumor
Sarcoma

Osteosarcoma
Osteogenic sarcoma
Soft tissue sarcomas
Rhabdomyosarcoma

Additional relevant MeSH terms:

Neoplasms, Muscle Tissue
Neoplasms
Neoplasms, Bone Tissue

Neoplasms by Histologic Type
Myosarcoma
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 15, 2009