Radiosurgery in Treating Patients With Kidney Tumors
7 de julio de 2020 actualizado por: Case Comprehensive Cancer Center
Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates
RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors.
Secondary
- To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates.
Serum Blood Marker Objective:
- To determine if serum markers collected before and after radiation may give a predictive indication of tumor response.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients undergo placement of 2-3 fiducial markers in or near the renal tumor. Patients then undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or unacceptable toxicity. Treatment may repeat at 6 months if tumor is still present.
After radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months post radiosurgery for a total of 36 months.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
31
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106-5065
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
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Orange Village, Ohio, Estados Unidos, 44122
- UH-Chagrin Highlands
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Westlake, Ohio, Estados Unidos, 44145
- UH-Westlake
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patient is considered a poor surgical candidate for removal of renal mass as determined by anesthesiology pre-operative assessment or the surgical team, medical team. (No major psychiatric illnesses.)
- Patient is able to give and sign study specific informed consent
- No prior radiation to the treatment field
- Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
- Patient has a radiologically and /or pathologically confirmed diagnosis of a renal tumor
- Karnofsky status of ≥ 60%
- Signed study-specific informed consent prior to study entry
Exclusion Criteria:
- Any patient not meeting the eligibility criteria.
- Any patient with active connective tissue disease such as lupus, dermatomyositis.
- Any patient with active Crohn's disease or active ulcerative colitis.
- Major psychiatric illness, which would prevent completion of treatment or interfere with follow-up.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Series 1: Stereotactic radiosurgery
Series I: Radiation will be delivered in 4 fractions.
The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions.
Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.
|
Series I: Radiation will be delivered in 4 fractions. Series II: Radiation will be delivered in 3 fractions.
At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
ELISA blood testing just prior to and immediately following each daily radiation therapy session.
Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
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Experimental: Series 2: Stereotactic radiosurgery
Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction.
If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy.
Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.
|
Series I: Radiation will be delivered in 4 fractions. Series II: Radiation will be delivered in 3 fractions.
At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
ELISA blood testing just prior to and immediately following each daily radiation therapy session.
Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maximum Tolerated Dose of Radiosurgery
Periodo de tiempo: once every 4 weeks
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Dose escalation stops if 2/4 (50%) or 3/8 (37.5%) of participants experience DLTs in a given dose level cohort.
The maximum tolerated dose will be one dose level below which the DLTs were exceeded.
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once every 4 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Survival
Periodo de tiempo: at 36 months from start of therapy
|
Radiographic efficacy as measured by overall (percent of participants still alive after study completion)
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at 36 months from start of therapy
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Progression-free Survival
Periodo de tiempo: at 36 months from start of therapy
|
Percent of participants still alive and without tumor progression at study completion
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at 36 months from start of therapy
|
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Freedom From Local Progression
Periodo de tiempo: at 36 months from start of therapy
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Radiographic efficacy as measured as measured by freedom from local progression (percent of participants without local progression or local recurrence after study completion)
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at 36 months from start of therapy
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Freedom to Distant Recurrence
Periodo de tiempo: at 36 months from start of therapy
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Radiographic efficacy as measured by distant recurrance (percent of participants without distant failure after study completion)
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at 36 months from start of therapy
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mitchell Machtay, MD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
20 de febrero de 2007
Finalización primaria (Actual)
12 de marzo de 2017
Finalización del estudio (Actual)
12 de septiembre de 2019
Fechas de registro del estudio
Enviado por primera vez
9 de abril de 2007
Primero enviado que cumplió con los criterios de control de calidad
9 de abril de 2007
Publicado por primera vez (Estimar)
11 de abril de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de julio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
7 de julio de 2020
Última verificación
1 de julio de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CASE12806 (Otro identificador: Case Comprehensive Cancer Center)
- P30CA043703 (Subvención/contrato del NIH de EE. UU.)
- NCI-2010-01064 (Otro identificador: NCI/CTRP)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
No
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