Radiation Therapy to Treat Musculoskeletal Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Lance Armstrong Foundation
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00186992
First received: September 12, 2005
Last updated: July 22, 2014
Last verified: July 2014
  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: image-guided radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group 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:


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

Primary Outcome Measures:
  • Cumulative incidence of local control, pattern of failure (local or metastatic) [ Time Frame: Time to local failure (local control) over 5 years follow-up after completion of therapy ] [ Designated as safety issue: No ]
    To estimate local control rates with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST).

  • Cumulative incidence of local control, pattern of failure (local or metastatic) [ Time Frame: Time to local failure (local control) over 10 years follow-up after completion of therapy ] [ Designated as safety issue: No ]
    To estimate local control rates with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST).


Secondary Outcome Measures:
  • Changes in growth rate and length of bone, bone density, development of muscle (muscle function, e.g. range of motion), occurrence of organ specific (e.g. lung, skin) CTC measured toxicities. [ Time Frame: Time to local failure (local control) over 5 years follow-up after completion of therapy ] [ Designated as safety issue: No ]
    Investigate the dose and volume relationship for the developing physis and cortical bone using physical measures and imaging evaluations.

  • Changes in growth rate and length of bone, bone density, development of muscle (muscle function, e.g. range of motion), occurrence of organ specific (e.g. lung, skin) CTC measured toxicities. [ Time Frame: Time to local failure (local control) over 10 years follow-up after completion of therapy ] [ Designated as safety issue: No ]
    Investigate the dose and volume relationship for the develop8ing physis and cortical bone using physical measures and imaging evaluations.

  • Muscle function over time, PET, DCE-MR, T2* MR quantitative parameters. [ Time Frame: Change from baseline as well as comparison to non-treated side (when available) during the first 5 years after completion of therapy. ] [ Designated as safety issue: No ]
    Describe the severity and time course of radiation-induced changes in the soft tissues and adjacent organs, including muscle and subcutaneous tissues.


Estimated Enrollment: 280
Study Start Date: January 2003
Estimated Study Completion Date: January 2024
Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment
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: image-guided 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.
    • 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.

    • 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.
  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 (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 (5.0).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
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:
Publications:
Hua C.; T.E. Merchant; S.L. Spunt; M.J. Krasin. Early Results of a Prospective Study Delivering Limited Margin Radiotherapy for Pediatric Patients With Rhabdomyosarcoma International journal of radiation oncology, biology, physics (volume 69 issue 3 Page S37), 2007
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: July 22, 2014
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
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 August 26, 2014