Image Guided Radiotherapy for the Treatment of Musculoskeletal Tumors: A Phase II Prospective Evaluation of Radiation-related Treatment Effects
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
- 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.
- Provide a long term (>5 year) estimate of local disease 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
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.
o 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 and alter long bone length
can be quantitatively identified.
- Quantitatively explore the impact of radiation on cortical bone thinning and long
- Relate radiation dose and volume to late (10+ year) alterations in bone integrity.
- 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, muscle function and organ
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cumulative incidence of local control, pattern of failure (local or metastatic)
To estimate local control rates with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST).
Time to local failure (local control) over 5 years follow-up after completion of therapy
Matthew Krasin, MD
St. Jude Children's Research Hospital
United States: Institutional Review Board
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|