Overview

This trial is active, not recruiting.

Conditions sarcoma, ewing's, rhabdomyosarcoma, soft tissue sarcoma, musculoskeletal tumors
Treatment image-guided radiotherapy
Phase phase 2
Sponsor St. Jude Children's Research Hospital
Collaborator Lance Armstrong Foundation
Start date January 2003
End date January 2024
Trial size 280 participants
Trial identifier NCT00186992, NCI-2011-01222, RTSARC

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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.
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.

Primary Outcomes

Measure
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
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

Secondary Outcomes

Measure
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
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
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.

Eligibility Criteria

Male or female participants up to 25 years old.

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).

Additional Information

Official title Image Guided Radiotherapy for the Treatment of Musculoskeletal Tumors: A Phase II Prospective Evaluation of Radiation-related Treatment Effects
Principal investigator Matthew Krasin, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by St. Jude Children's Research Hospital.