- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01340495
Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy
Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be assessed weekly for any side effects they may be experiencing.
Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12 months, and then every year for up to five years after treatment. Follow-up visits will include a physical examination, radiological imaging (if necessary), echocardiogram, and laboratory tests.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Histologically confirmed invasive breast cancer confined to the breast and regional lymphatics
- Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery
- Life expectancy > 12 months
Exclusion Criteria:
- Pregnant or breast-feeding
- Prior therapeutic radiation > 200 cGy
- History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin
- Prior investigation chemotherapy
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Proton Radiation
Radiation therapy with proton beam
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45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event
Prazo: From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
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To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or > radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment.
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From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
The Number of Participants With Acute Skin Toxicities
Prazo: From the start of treatment until 3 months after the end of treatment
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Summary of the number of participants with any grade acute skin toxicities.
Acute skin toxicity was assessed from the start of treatment until 90 days after the end of treatment.
Skin toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
|
From the start of treatment until 3 months after the end of treatment
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Rate and Severity of Radiation Pneumonitis
Prazo: From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.
|
The number of participants that experienced radiation pneumonitis within three months of the end of treatment. The participants that experienced radiation pneumonitis are grouped by grade. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
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From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.
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Summary of Late Skin Toxicity
Prazo: From 3 months after the end of treatment up to 5 years
|
A summary of the late skin toxicities experienced by participants.
The number of participants effected is shown for each toxicity experienced.
Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
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From 3 months after the end of treatment up to 5 years
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To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome
Prazo: From the start of treatment until 5 years post treatment
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From the start of treatment until 5 years post treatment
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Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation
Prazo: From the start of treatment until 5 years post treatment
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Combined summary of the acute (within 3 months of completing treatment) and late (3 months to 5 years after completion of treatment) toxicities experienced by participants thought to be related to breast reconstruction surgery following proton radiation treatment.
Toxicities are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
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From the start of treatment until 5 years post treatment
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The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction
Prazo: From the start of treatment until 5 years post treatment
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From the start of treatment until 5 years post treatment
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The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy
Prazo: Baseline and then 4 and 8 weeks post treatment
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The number of participant that had early signs of cardiac effects from radiation therapy as assessed using a Strain Echo-cardiogram.
The data from the Echo-cardiogram was evaluated for signs of negative impacts to cardiac function as determined by the treating physician.
Parameters considered in the evaluation of the echo-cardiogram by the physician included myocardial velocity, strain, strain rate, and torsion.
Blood-based cardiac bio-markers pro-BNP and ultra-sensitive troponin-I were also assessed.
Either a clinically meaningful change in the strain echo-cardiogram parameters or clinically meaningful elevation of the bio-markers was sufficient to be considered to have early signs of cardiac effects.
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Baseline and then 4 and 8 weeks post treatment
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Progression Free Survival
Prazo: from the start of treatment until the time of disease progression, up to 5 years
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Progression-free survival is defined as the duration from the start of radiation to the date of objective disease progression or death due to any cause, whichever is earlier.
Disease progression is defined as the appearance of one or more new lesions.
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from the start of treatment until the time of disease progression, up to 5 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Shannon M MacDonald, M.D., Massachusetts General Hospital
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 10-205
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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