Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186992
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2005-09-12
Brief Title:
Radiation Therapy to Treat Musculoskeletal Tumors
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Image Guided Radiotherapy for the Treatment of Musculoskeletal Tumors A Phase II Prospective Evaluation of Radiation-related Treatment Effects
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Researchers at St Jude Childrens 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
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 Ewings 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 Ewings 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 Ewings 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
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 Ewings 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 Ewings 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 Ewings 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-01222 | REGISTRY | NCI Clinical Trial Registration Program | None |