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Image Guided Radiotherapy for the Treatment of Musculoskeletal Tumors: A Phase II Prospective Evaluation of Radiation-related Treatment Effects


Phase 2
N/A
25 Years
Open (Enrolling)
Both
Sarcoma, Ewing's, Rhabdomyosarcoma, Soft Tissue Sarcoma, Musculoskeletal Tumors

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Trial Information

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
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.

- 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
therapy.

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
bone curvature.

- 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.


Inclusion Criteria:



- Age less than or equal to 25 years (new enrollments only). No age limit on
participants who reconsent or reenroll.

- 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 except for emergent radiation to
the primary site lasting 1 week or less (5 treatment days) that can be dosimetrically
accounted for in the analysis.

- 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 4.0, who are still in active participation will
be reconsented to the current version of the protocol (4.0).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cumulative incidence of local control, pattern of failure (local or metastatic)

Outcome Description:

To estimate local control rates with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST).

Outcome Time Frame:

Time to local failure (local control) over 5 years follow-up after completion of therapy

Safety Issue:

No

Principal Investigator

Matthew Krasin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

RTSARC

NCT ID:

NCT00186992

Start Date:

January 2003

Completion Date:

January 2024

Related Keywords:

  • Sarcoma, Ewing's
  • Rhabdomyosarcoma
  • Soft Tissue Sarcoma
  • Musculoskeletal Tumors
  • Sarcoma
  • radiation therapy
  • Other musculoskeletal tumors
  • Rhabdomyosarcoma
  • Sarcoma, Ewing's
  • Sarcoma

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794