Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer (HIPECStomach)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30% of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its five-year survival rate is less than 2%. Even after R0 resection of a localized gastric carcinoma the five-year survival rate is only 40%, not least of all because relapses in the form of peritoneal metastases are a common occurrence.
Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which stands in strong contrast to the 40% risk for patients with negative cytology.
In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion (HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin will be administered following gastrectomy in patients with a gastric carcinoma with free tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B) solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells diagnosed in cytology in the preoperative laparoscopy.
A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM Stage ≥ T2<T4) without proven metastases (TNM stage M0), with and without involved regional lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal lavage will be included. Exclusion criteria are extended disease or inoperable tumor.
This study is already permitted by the local ethic commission and the German Federal Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code: HIPEC_Stomach) and was initiated in August 2012.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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BW
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Tuebingen, BW, Alemania, 72076
- University of Tuebingen
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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 proven gastric adenocarcinoma: uT1,uT2, uT3, Nx, M0
- No prior chemotherapy
- Patients of full age, independent of gender ECOG ≤ 2
- No dissemination of the tumor confirmed by CT of the lung and the abdomen.
- Signed Consent form of the Patient agreeing to investigations
- Leucocytes > 3.000/µl
- Thrombocytes > 100.000/µl
- Creatinine ≤ 1.5mg/dl and or Clearance > 60 ml/min
- informed consent of the patient
- normal ejection-fraction of the heart
Exclusion Criteria:
- Dissemination of the tumor or non-resectable primary tumor
- Malignant secondary disease < 5 years in the past (Exception: in-situ-carcinoma of the cervix and appropriately treated basal cell carcinoma of the skin)
- Patient not of full age
- Inflammatory chronic bowel disease
- Inclusion of the patient in a different study
- Pregnancy or lactation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: positive cytology with HIPEC
gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative
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HIPEC with mytomycin and cisplatin
Otros nombres:
|
|
Sin intervención: positive cytology without HIPEC
gastric cancer cytology positive without HIPEC
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|
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Sin intervención: negative cytology without HIPEC
gastric cancer with negative cytology
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Peritoneal Carcinosis Free Survival
Periodo de tiempo: 5 Years
|
Three patients were enrolled in the study.
No study results because no patient has received study drug.
|
5 Years
|
|
Disease Free Survival
Periodo de tiempo: 5 years
|
No study results because no patient has received study drug.
|
5 years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Procedure Related Complication
Periodo de tiempo: 60 days
|
No study results because no patient has received study drug.
|
60 days
|
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Kinetics of Mitomycin and Cisplatin
Periodo de tiempo: 24 hours after application
|
24 hours after application
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alfred Königsrainer, MD, University Hospital Tuebingen
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 (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
- Enfermedades del Sistema Digestivo
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Enfermedades Peritoneales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Estómago
- Neoplasias Abdominales
- Neoplasias de Estómago
- Carcinoma
- Neoplasias Peritoneales
- Agentes antineoplásicos
- Cisplatino
Otros números de identificación del estudio
- 2011-004405-25
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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