Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS (SPARTACUS)
Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS): A Phase I/II Study (SPARTACUS)
Advanced technology has enabled radiation oncologists to more accurately and precisely target radiation to areas at risk while maximally sparing healthy tissue. A secondary result of these technologic advances has been the increased utilization of hypofractionationed treatment protocols, since the combined ability to better visualize and precisely deliver radiation to target volumes has allowed radiation oncologists to leverage the therapeutic ratio toward higher target doses whilst maintaining safe doses to the pertinent organs-at-risk. The spectrum of hypofractionation ranges from what are considered moderate (ie. 2- 5 Gy / fraction) into the realm of what is more commonly referred to as stereotactic body (SBRT), generally >5 Gy / fraction. There is growing evidence demonstrating both safety and efficacy for SBRT. The investigators propose that these advantages are translatable to the adjuvant treatment of endometrial cancer.
The investigators submit that a prescription dose of 30 Gy in 5 fractions. Through precision delivery and careful dosimetry the treatment should be safe and well tolerated with minimal impact on patient quality of life.
Visão geral do estudo
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Ontario
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Toronto, Ontario, Canadá, M4N 3M5
- Sunnybrook Health Sciences Centre
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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 endometrial adenocarcinoma
Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions:
- Patient has serous, clear cell, carcinosarcoma or differentiated histologies.
- Outer-half myometrial invasion and FIGO grade 1-2 OR
- FIGO stage II - IIIC1.
- Willing and able to give informed consent to participate in this clinical trial.
- Age ≥18 years.
- Are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments.
- Willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol.
- Primary language of the patient must be English or, if a patient's primary language is not English, they are still able to participate provided the QLQ-C30 and EN-24 is available in their primary language.
Exclusion Criteria:
- Has had prior pelvic radiotherapy.
- Has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
- Has a contraindication to iodinated CT contrast.
- Has a hip prosthesis.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Hypofractionated Pelvic Radiation
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Patients will be planned with the aim of delivering 30 Gy in 5 fractions.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Acute toxicities
Prazo: Baseline to 12 weeks following RT completion
|
To assess the acute urinary and bowel toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer using CTCAE.
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Baseline to 12 weeks following RT completion
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of life through EORTC QLQ-C30 and EN24
Prazo: Study activation through 2 years post-RT
|
To assess the effect of adjuvant SBRT treatment on acute and late patient reported health quality of life using EORTC questionnaires.
|
Study activation through 2 years post-RT
|
|
Late toxicities
Prazo: 12 weeks post-RT to 2 years post-RT
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To assess the late urinary, bowel, and other toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer using CTCAE.
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12 weeks post-RT to 2 years post-RT
|
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Local-regional failure
Prazo: Study activation through 2 years post-RT
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To assess the local-regional failure of adjuvant SBRT treatment by observation of progression or persistence of disease.
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Study activation through 2 years post-RT
|
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Disease-free survival
Prazo: Study activation through 2 years post-RT
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To document the disease-free survival of those treated with adjuvant SBRT
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Study activation through 2 years post-RT
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Dosimetric feasibility
Prazo: Baseline to RT completion
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The number of patients eligible for enrollment at a 30Gy prescription dose based rigid dosimetric constraints, as compared to a 27.5 Gy treatment dose.
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Baseline to RT completion
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eric Leung, MD, Sunnybrook Health Sciences Centre
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
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 (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SPARTACUS
Plano para dados de participantes individuais (IPD)
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