Radioterapia intraoperatoria después de la radioterapia corporal estereotáctica y la quimioterapia en el tratamiento del adenocarcinoma de páncreas
Un estudio de seguridad de la radioterapia intraoperatoria después de la radioterapia corporal estereotáctica y la quimioterapia con múltiples agentes en el tratamiento del adenocarcinoma pancreático localizado
This study is designed to investigate the safety of intraoperative radiation therapy (IORT) in patients with localized pancreatic cancer undergoing surgical resection after neoadjuvant chemotherapy and stereotactic body radiation therapy (SBRT).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Standard of care treatment for patients with non-metastatic pancreatic adenocarcinoma (PDAC) includes chemotherapy and Stereotactic Body Radiation Treatment (SBRT) followed by surgical resection of the tumor with or without Intra-Operative Radiation Therapy (IORT).
There is some evidence from other research studies suggesting that adding radiation treatment during the surgical resection may improve local control of the cancer. The use of IORT plus surgical resection can be used to treat pancreatic cancer and is done on a case by case basis at Johns Hopkins.
The department of Radiation Oncology has developed a program using a High Dose Rate-IORT (HDR-IORT). The HDR-IORT makes it possible to deliver concentrated radiation dose at the surface of the tumor.
Our team has shown in previous studies that the majority of cancer cells that remain after treatment are located around the area of the pancreas called the "Triangle Volume" (TV). This region contains blood vessels, lymphatic vessels, and nerves, and is at high risk of containing cancer cells. This region is difficult to treat with SBRT alone because of being close to normal, healthy organs. Therefore, this study involves using IORT to treat the TV to a therapeutic radiation dose.
The part of the treatment that is considered research is:
- Giving one dose of 15 Gy during the surgery using IORT to deliver radiation, and
- Targeting the larger area around the pancreas called the TV
The goal of this study is to determine safety of this added treatment which will be assessed at 3 months after the surgery is completed.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins Hospital
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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
- Resectable/BRPC/LAPC as defined by NCCN guidelines (Figure 1) as follows confirmed via CT, EUS, or other imaging modalities.
- ECOG performance status 0-2
- Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
- Candidate for SBRT at JHU
- Upfront treatment with multi-agent chemotherapy
- Candidate for surgical exploration at JHU
Exclusion Criteria:
- Previous thoracic/abdominal radiation therapy
- Unable to receive SBRT at JHU
- Duodenal invasion detected on imaging which would exclude candidacy for SBRT
- Tumor located in pancreatic body or tail
- Unable to undergo Whipple procedure
- Evidence of disease not localized to the pancreas
- Any arterial reconstruction during surgery
- Currently enrolled in another investigational drug or device trial that clinically interferes with this study
- Unable to comply with study requirements or follow-up schedule
- Women of child bearing potential or sexually active fertile men with partners who are women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study
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 |
|---|---|
|
Otro: Intra Operative Radiation Therapy (IORT) Group
The IORT group is the single arm of this study. Enrolled patients who undergo standard of care treatment will also receive a study treatment of High Dose Rate (HDR) Intra Operative Radiation Therapy. |
After the patient receives standard of care treatment, they will receive a single dose of radiation (15 Gy) at the time the tumor is surgically removed. Surgeons will then place clips along the blood vessels around the surgical area. These clips will be used to confirm (after surgery) that the expected dose of radiation was received during surgery. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acute post-operative toxicity of targeted IORT
Periodo de tiempo: 3 months
|
To evaluate acute post-operative toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT. |
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Late post-operative toxicity of targeted IORT
Periodo de tiempo: 6 months
|
To evaluate late toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT. To evaluate late toxicity (>90 days) of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT. |
6 months
|
|
Late post-operative toxicity of targeted IORT
Periodo de tiempo: 12 months
|
To evaluate late toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT. To evaluate late toxicity (>90 days) of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT. |
12 months
|
|
Late post-operative toxicity of targeted IORT
Periodo de tiempo: 24 months
|
To evaluate late toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT. To evaluate late toxicity (>90 days) of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT. |
24 months
|
|
Late post-operative toxicity of targeted IORT
Periodo de tiempo: 36 months
|
To evaluate late toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT. To evaluate late toxicity (>90 days) of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT. |
36 months
|
|
Median local-progression free survival (LPFS) from IORT
Periodo de tiempo: 6 months
|
To determine the median local-progression free survival (LPFS) from time of IORT. |
6 months
|
|
Median local-progression free survival (LPFS) from IORT
Periodo de tiempo: 12 months
|
To determine the median local-progression free survival (LPFS) from time of IORT. |
12 months
|
|
Median local-progression free survival (LPFS) from IORT
Periodo de tiempo: 24 months
|
To determine the median local-progression free survival (LPFS) from time of IORT. |
24 months
|
|
Median local-progression free survival (LPFS) from IORT
Periodo de tiempo: 36 months
|
To determine the median local-progression free survival (LPFS) from time of IORT. |
36 months
|
|
Median overall survival (OS) from IORT
Periodo de tiempo: 6 months
|
To determine the median overall survival (OS) from time of IORT. |
6 months
|
|
Median overall survival (OS) from IORT
Periodo de tiempo: 12 months
|
To determine the median overall survival (OS) from time of IORT. |
12 months
|
|
Median overall survival (OS) from IORT
Periodo de tiempo: 24 months
|
To determine the median overall survival (OS) from time of IORT. |
24 months
|
|
Median overall survival (OS) from IORT
Periodo de tiempo: 36 months
|
To determine the median overall survival (OS) from time of IORT. |
36 months
|
|
Median progression free survival (PFS) from IORT
Periodo de tiempo: 6 months
|
To determine the median progression free survival (PFS) from time of IORT |
6 months
|
|
Median progression free survival (PFS) from IORT
Periodo de tiempo: 12 months
|
To determine the median progression free survival (PFS) from time of IORT |
12 months
|
|
Median progression free survival (PFS) from IORT
Periodo de tiempo: 24 months
|
To determine the median progression free survival (PFS) from time of IORT |
24 months
|
|
Median progression free survival (PFS) from IORT
Periodo de tiempo: 36 months
|
To determine the median progression free survival (PFS) from time of IORT |
36 months
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Amol Narang, MD, JHU, School of Medicine, SKCCC
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
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
- J21105
- IRB00294801 (Otro identificador: Johns Hopkins Medicine)
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.
producto fabricado y exportado desde los EE. UU.
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