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O estudo clínico NCT03972930 para Sarcoma de Tecidos Moles 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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Hypofractionated Radiotherapy for Soft Tissue Sarcomas Fase II 48

Ativo, não recrutando
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 NCT03972930 procura avaliar tratamento para Sarcoma de Tecidos Moles. Este é um estudo intervencionista de Fase II. Seu status atual é: ativo, não recrutando. O estudo começou em 11 de junho de 2019 e pretende incluir 48 participantes. Coordenado por a Universidade do Wisconsin-Madison e deve ser concluído em 1 de dezembro de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 17 de janeiro de 2025.
Resumo
One of the main challenges in treating sarcomas with radiation is the toxicity to normal structures around the sarcoma. Early reports suggest Hypofractionated Radiotherapy will be safe and effective for treatment of soft tissue sarcomas. However, given the rarity of this disease, the diversity of histological sub-types, and the variety of locations where these can occur (anywhere in the body), more data is needed to ...Mostrar mais
Título oficial

Phase 2 Trial of Hypofractionated Radiotherapy for Soft Tissue Sarcomas

Condições médicas
Sarcoma de Tecidos Moles
Outros IDs do estudo
  • UW18149
  • 2019-0360 (Outro identificador) (Institutional Review Board)
  • A533300 (Outro identificador) (UW Madison)
  • SMPH/HUMAN ONCOLOGY/HUMAN ONCO (Outro identificador) (UW Madison)
  • NCI-2019-03768 (Identificador de registro) (NCI Trial ID)
  • Protocol Version 5/5/2021 (Outro identificador) (UW Madison)
Número NCT
NCT03972930
Data de início (real)
2019-06-11
Última atualização postada
2025-01-17
Data de conclusão (estimada)
2027-12
Inscrição (estimada)
48
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Ativo, não recrutando
Palavras-chave
Hypofractionated Radiotherapy
Propósito principal
Tratamento
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalHypofractionated Radiotherapy for Soft Tissue Sarcoma
Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks.
Radioterapia hipofracionada
Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Proportion of Participants with 2-year Local Control
The primary endpoint is 2-year local control, defined as the proportion of participants whose best response as determined per RECIST criteria using imaging is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) out of all participants who have received at least one fraction. Local control will be reported with an exact 95% confidence interval (CI).
up to 2 years
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Proportion of Participants with 2-year Local Control: Primary Site vs Metastatic Site
2-year local control rates will be reported separately for primary sites vs. metastatic sites with exact 95% CI.
up to 2 years
Proportion of Participants with 5-year Local Control: Primary Site vs Metastatic Site
5-year local control rates will be reported separately for primary sites vs. metastatic sites with exact 95% CI.
up to 5 years
Complete Response Rate
The complete response (CR) rate will be reported with an exact 95% CI.
up to 5 years
Progression Free Survival
Progression free survival (PFS) defined with follow-up radiological assessment with PFS calculated from the point of start of hypofractionated radiotherapy to the point of recurrence or death. Participants without documented progression who are alive at last follow-up will be censored at the date of the last radiologic assessment. PFS will be estimated using the Kaplan-Meier method.
up to 5 years
Overall Survival
Overall survival (OS) defined from the point of start of hypofractionated radiotherapy to the time of death or last follow-up if alive. Participants who are alive at last follow-up will be censored. OS will be estimated using the Kaplan-Meier method.
up to 5 years
Incidence of Acute Toxicity
Tabulated by type and grade.
up to 8 weeks
Incidence of Long Term Toxicity
Tabulated by type and grade.
up to 5 years
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
  • Biopsy proven soft tissue sarcoma, either localized and inoperable/unresectable or metastatic, that is deemed by the treating physician to be targetable with hypofractionated radiotherapy.
  • Participant refuses surgery or is aware that surgery is not recommended for them
  • Karnofsky performance status > 60
  • Able to understand and sign an informed consent form

  • Pregnant
  • Chemotherapy or systemic anti-cancer treatment within the preceding two weeks
  • Unable to undergo imaging or positioning necessary for radiotherapy planning
  • Prior radiation therapy in the field that, at the discretion of the treating physician, prevents safe delivery of hypofractionated radiotherapy.
University of Wisconsin, Madison logoUniversidade do Wisconsin-Madison243 estudos clínicos ativos para explorar
Sem dados de contato.
1 Locais do estudo em 1 países

Wisconsin

University of Wisconsin, Madison, Wisconsin, 53705, United States