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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ontario
-
Toronto, Ontario, Canadá, M4N 3M5
- Sunnybrook Health Sciences Centre
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Hypofractionated Pelvic Radiation
|
Patients will be planned with the aim of delivering 30 Gy in 5 fractions.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acute toxicities
Periodo de tiempo: 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.
|
Baseline to 12 weeks following RT completion
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of life through EORTC QLQ-C30 and EN24
Periodo de tiempo: 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
Periodo de tiempo: 12 weeks post-RT to 2 years post-RT
|
To assess the late urinary, bowel, and other toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer using CTCAE.
|
12 weeks post-RT to 2 years post-RT
|
|
Local-regional failure
Periodo de tiempo: Study activation through 2 years post-RT
|
To assess the local-regional failure of adjuvant SBRT treatment by observation of progression or persistence of disease.
|
Study activation through 2 years post-RT
|
|
Disease-free survival
Periodo de tiempo: Study activation through 2 years post-RT
|
To document the disease-free survival of those treated with adjuvant SBRT
|
Study activation through 2 years post-RT
|
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Dosimetric feasibility
Periodo de tiempo: Baseline to RT completion
|
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.
|
Baseline to RT completion
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eric Leung, MD, Sunnybrook Health Sciences Centre
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SPARTACUS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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