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O estudo clínico NCT00186992 para Sarcoma, Ewing's, Rabdomiossarcoma, Sarcoma de Tecidos Moles, Musculoskeletal Tumors está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Radiation Therapy to Treat Musculoskeletal Tumors Fase II 202 Pediátrico
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT00186992 procura avaliar tratamento para Sarcoma, Ewing's, Rabdomiossarcoma, Sarcoma de Tecidos Moles, Musculoskeletal Tumors. Este é um estudo intervencionista de Fase II. Seu status atual é: ativo, não recrutando. O estudo começou em 10 de janeiro de 2003 e pretende incluir 202 participantes. Coordenado por St. Jude Children's Research Hospital e deve ser concluído em 1 de outubro de 2029. Essas informações foram atualizadas no ClinicalTrials.gov em 4 de março de 2026.
Resumo
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 em...Mostrar mais
Descrição detalhada
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 ...
Título oficial
Image Guided Radiotherapy for the Treatment of Musculoskeletal Tumors: A Phase II Prospective Evaluation of Radiation-related Treatment Effects
Condições médicas
Sarcoma, Ewing'sRabdomiossarcomaSarcoma de Tecidos MolesMusculoskeletal TumorsPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
Número NCT
Data de início (real)
2003-01-10
Última atualização postada
2026-03-04
Data de conclusão (estimada)
2029-10
Inscrição (estimada)
202
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Ativo, não recrutando
Palavras-chave
Sarcoma
radiation therapy
Other musculoskeletal tumors
radiation therapy
Other musculoskeletal tumors
Propósito principal
Tratamento
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
OutroTreatment 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. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Cumulative Incidence of Local Failures at 5 Years in Patients With Image Guided Radiation Therapy | The cumulative incidence of local failures is used to report the control of local failures in patients with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST). | 5-years follow-up after completion of therapy. |
Cumulative Incidence of Local Failures at 10 Years in Patients With Image Guided Radiation Therapy | The cumulative incidence of local failures is used to report the control of local failures in patients with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST). | 10- years follow-up after completion of therapy |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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. | Investigate the dose and volume relationship for the developing physis and cortical bone using physical measures and imaging evaluations. | 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. | Investigate the dose and volume relationship for the developing physis and cortical bone using physical measures and imaging evaluations. | 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. | Describe the severity and time course of radiation-induced changes in the soft tissues and adjacent organs, including muscle and subcutaneous tissues. | Change from baseline as well as comparison to non-treated side (when available) during the first 5 years after completion of therapy. |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto
Sexos elegíveis
Todos
- 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).
St. Jude Children's Research HospitalLance Armstrong FoundationSem dados de contato.
1 Locais do estudo em 1 países
Tennessee
St. Jude Children's Research Hospital, Memphis, Tennessee, 38105, United States