Status:
ACTIVE_NOT_RECRUITING
Radiation Therapy to Treat Musculoskeletal Tumors
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Lance Armstrong Foundation
Conditions:
Sarcoma, Ewing's
Rhabdomyosarcoma
Eligibility:
All Genders
Up to 25 years
Phase:
PHASE2
Brief 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 impr...
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
January 10 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2029
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00186992
Start Date
January 10 2003
End Date
October 1 2029
Last Update
March 6 2025
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105