Radiation Therapy to Treat Musculoskeletal Tumors - Full Text View

Sponsor:	St. Jude Children's Research Hospital
Collaborator:	Lance Armstrong Foundation
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Image Guided Radiotherapy for the Treatment of Musculoskeletal Tumors: A Phase II Prospective Evaluation of Radiation-related Treatment Effects

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

U.S. FDA Resources

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:	October 2017
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Eligible patients will be accessioned at the time of irradiation and undergo 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.

Detailed Description:

The study focuses on the following primary Objectives:

To estimate local control rates with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST).
Prospectively establish a baseline estimate of local control for patients with MST (Ewing's sarcoma family of tumors (ESFT), rhabdomyosarcoma (RMS) and non-rhabdomyosarcoma soft tissue sarcoma (STS)) treated with image guided radiation therapy.
Demonstrate that the increased level of conformality afforded by image guided radiation therapy does not reduce its efficacy relative to previously utilized non-image guided radiation therapy techniques in patients with Ewing's sarcoma family of tumors, resected soft tissue sarcomas, and group III rhabdomyosarcomas.
Assess local and regional patterns of failure for patients with MST treated with image guided radiation therapy relative to their targeted volumes.

The study focuses on the following secondary objectives:

Establish a quantitative baseline estimate of radiation dose-related changes in normal tissues using novel objective measures of somatic change, musculoskeletal function, tissue biochemistry and physiology.
Investigate the dose and volume relationship for the developing physis and cortical bone using physical measures and imaging evaluations including:
Prospectively investigate whether an age based radiotherapeutic threshold of dose and volume that will induce premature physis closure can be quantitatively identified.
Quantitatively explore the impact of radiation on cortical bone thinning and long bone curvature.
Describe the severity and time course of radiation-induced changes in the soft tissues including muscle and subcutaneous tissues.
Delineate sequential changes in muscular volume and function (delineated by imaging and measures of physical function) following image guided radiation for specific muscular groups.
Correlate the temporal changes in muscular volume and function with changes in vascularity and metabolism defined by imaging studies.
Relate prospectively documented changes in subcutaneous tissues (by physical measure and imaging) to dosimetric parameters.

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 No prior therapeutic irradiation at the primary site
Negative serum or urine beta-HCG for females of child bearing age
Patients will be stratified into 2 groups for evaluation of secondary objective endpoints based on the absence or presence of metastatic disease.
Patients may enter this study in specific clinical situations often defined by multimodality protocols that include the use of radiation therapy, including irradiation alone or combined with surgery (following surgical resection that may be macroscopically complete or incomplete, with positive or negative histologic margins) and/or chemotherapy (following neoadjuvant chemotherapy or combined with post-irradiation adjuvant chemotherapy).Patients requiring regional nodal irradiation and/or metastatic site irradiation are allowed as long as the primary site requires radiation.Patients with recurrent tumors or second malignant neoplasms are allowed on this study if the current primary tumor site requiring irradiation has not previously been irradiated.The treatment plan detailed in this study will allow most patients to be concurrently enrolled on institutional and COG studies.
Patients enrolled prior to amendment 3.0, who are still in active participation will be reconsented to the current version of the protocol (3.2).

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

Additional 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.

M.J. Krasin; X. Xiong; L. Zhang; W.E. Reddick; T.E. Merchant. A Prospective Study of Quantitative Changes in the Musculature of Children Treated with Radiation Therapy for Sarcomas International journal of radiation oncology, biology, physics(volume 63 issue Pages S443-S444), 2005

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

Krasin MJ,MD; Ziong X, PhD; Lijun Z, PhD; Reddick WE, PhD; Merchant TE, DO, PhD. A Model for Quantitiative Changes in The Magnetic Resonance Parameters of Muscle in Children after Therapeutic Irradiation (Presented ASTRO 2005)

Responsible Party:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00186992 History of Changes
Other Study ID Numbers:	RTSARC
Study First Received:	September 12, 2005
Last Updated:	October 18, 2011
Health Authority:	United States: Institutional Review Board

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

Sarcoma
radiation therapy
Other musculoskeletal tumors

Additional relevant MeSH terms:

Rhabdomyosarcoma
Sarcoma, Ewing's
Sarcoma
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type
Neoplasms
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on February 12, 2012