A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases (FASTRACK)
Descripción general del estudio
Descripción detallada
FASTRACK is a 2 -cohort, non-randomised prospective feasibility study. Anticipated total duration of accrual is approximately 24 months, with all patients expected to complete all protocol treatment and imaging within a further 3 months. The trial will close after the last patient has completed his/her last protocol related follow-up visit (at 12 months post-treatment).
Cohort 1: patients with renal cell carcinoma within the kidney Cohort 2: patients with solitary adrenal metastases from non-small cell lung carcinoma The investigational treatment will be prescribed the covering isodose, ensuring that 99% of the PTV is covered by 100% of the dose (D99=100%). It is anticipated that most treatments should be highly conformal. Treatment must be delivered with at least six (6) non-opposing conformal megavoltage photon beams. It is anticipated that a typical range of beam numbers would be 8 to 12, comprising of at least 6 co-planar beams and 1-2 non-coplanar beams. No cytotoxic chemotherapy is allowed within 3 weeks or concurrently with respect to the investigational treatment. Consultation with the treating radiation oncologist is strongly recommended if chemotherapy is to be considered after the investigational treatment and before documented disease progression, to prevent unforeseen combined toxicities. Targeted agents (such as sunitinib) are exempt from this recommendation.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Victoria
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East Melbourne, Victoria, Australia, 3002
- Peter MacCallum Cancer 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:
- Age > 18 years old
All patients must have radiological diagnosis or biopsy confirmed diagnosis of either:
- Cohort 1: renal cell carcinoma with a single lesion within kidney, or with primary kidney tumour intact and no more than 5 documented metastases, or
- Cohort 2: single adrenal metastases with extra-adrenal disease controlled
- ECOG performance of 0-2 inclusive.
- Either medically inoperable, technically high risk for surgery or decline surgery.
- Informed consent.
Exclusion Criteria:
- Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Delivery of targeted agents (such as sunitinib) are allowable only when at least 7 days separate the delivery of the proposed agent and the delivery of the stereotactic radiotherapy.
- Previous high-dose radiotherapy to upper abdomen
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Radiotherapy
The interventional treatment will be prescribed as a 2-tiered dose scheduled dependant of target size. For lesions <5cm, a single fraction of 26 Gy will be prescribed. For lesions ≥5cm a fractionated course of 15Gy by 3 fractions will be prescribed, delivered at least 48 hours apart. |
The investigational treatment will be prescribed as a 2-tiered dose scheduled dependant on target size. For lesions <5cm, a single fraction of 26Gy will be prescribed. For lesions ≥5cm a fractionated course of 14Gy by 3 fractions will be prescribed, delivered at least 48 hours apart. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The number of patients who complete prescribed treatment.
Periodo de tiempo: After 24 months
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This is defined as patients who successfully receive the treatment plan as prescribed, achieving all nominated dose constraints, and are able to tolerate the treatment(s)
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After 24 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Toxicity of SBRT in study patients measured using CTCAE V4.0
Periodo de tiempo: Between 2-4 weeks after radiotherapy and 3 monthly for 12 months
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Specific toxicities will include, but are not limited to;
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Between 2-4 weeks after radiotherapy and 3 monthly for 12 months
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Efficacy of stereotactic radiosurgery
Periodo de tiempo: 1 year after treatment
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Effective SBRT is defined as a treatment which results in local control at 1 year after treatment.
Local control is defined as lack of progression of the target lesion as measured by RECIST criteria.
RECIST criteria are a CT evaluation of change in tumour size.
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1 year after treatment
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Feasibility of using Diffusion weighted-MRI for response assessment.
Periodo de tiempo: At Baseline, 14 days (+/-3 days) and at the definitive response assessment (70days +/-10days)
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Feasibility will be measured by the quality of image of the diffusion weighted-MRI recorded by the investigating radiologists.
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At Baseline, 14 days (+/-3 days) and at the definitive response assessment (70days +/-10days)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shankar Siva, Peter MacCallum Cancer Centre, Australia
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 11/106
- U1111-1132-5574 (Identificador de registro: ANZCTR)
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