- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00811447
Taxotere New Indication - Gastric Cancer Treatment Registration Trial
Open Label, Randomized Multicenter Study Docetaxel + 5-fluorouracil + Cisplatin Compared to Cisplatin + 5-fluorouracil in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
Primary objective:
To detect a statistically significant increase in time to progression (TTP) of disease for the test group (Taxotere® [Docetaxel] combined with cisplatin and 5-fluorouracil [TCF]) relative to the control group (Cisplatin combined with 5-fluorouracil[CF])
Secondary objectives:
- To detect a statistically significant increase in overall survival (OS) for the test group relative to the control group.
- To compare response rate (RR), time to treatment failure (TTF), duration of responses, safety profiles, quality of life (QOL), and disease-related symptoms.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
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Shanghai, Porcelana
- Sanofi-Aventis Administrative Office
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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:
- Gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction, histologically proven.
- Measurable and/or evaluable metastatic disease; if a single metastatic lesion is the only manifestation of the disease, cytology or histology is mandatory. Locally recurrent disease is accepted provided that there is at least one measurable lesion.
- Performance status Karnofsky index >70%
- Life expectancy of more than 3 months
- Adequate haematological parameters (Hb≥9g/dl, ANC≥2.0× 109/L, platelets ≥ 100× 109/L)
- Creatinine ≤ 1.25 UNL, serum magnesium should be within the normal value
- Total bilirubin ≤ 1 UNL, AST and ALT ≤ 2.5 UNL, alkaline phosphatase ≤ 5 UNL
- No prior palliative chemotherapy, previous adjuvant chemotherapy is allowed if more than 12 months has elapsed between the end of adjuvant therapy and first relapse.
- At least 6 weeks from prior radiotherapy and 3 weeks from surgery
- Complete initial work-up within two weeks prior to first infusion for clinical evaluation and biological work-up. Abdominal CT scan and chest X-rays are mandatory.
Exclusion Criteria:
- Pregnant or lactating women
- Patients with reproductive potential not implementing adequate contraceptive measures
- Other tumor type than adenocarcinoma
- Any prior palliative chemotherapy. Prior adjuvant chemotherapy with a first relapse within 12 months from the end of adjuvant
- Prior treatment with taxanes. Prior CDDP as adjuvant chemotherapy with cumulative dose > 300mg/m²
- Previous or current malignancies other than gastric carcinoma, with the exception of adequately treated in situ carcinoma of the cervix uteri or non melanoma skin cancer
- Patients with known brain or leptomeningeal metastases
- Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria
Other serious illness or medical conditions:
- unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- history of significant neurologic or psychiatric disorders including dementia or seizures
- active uncontrolled infection
- active disseminated intravascular coagulation
- other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- Concurrent treatment with corticosteroids except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions or unless chronic treatment at low doses
- Definite contraindications for the use of corticosteroids
- Hypercalcemia not controlled by bisphosphonates and more than 12mg/100ml
- Liver impairment with AST or ALT more than 1.5UNL associated with alkaline phosphatase more than 2.5UNL
- Concurrent or within 4 week period administration of any other experimental drugs
- Concurrent treatment with any other anti-cancer therapy
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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: 1
Administration of docetaxel 60 mg/m² on Day 1, Cisplatin 60 mg/m² after the end of the docetaxel infusion and 5-fluorouracil (5-FU) 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5.
|
600 mg/m²/day intravenous
60 mg/m² or 75 mg/m² intravenous
60 mg/m² intravenous
|
Comparador activo: 2
Cisplatin 75 mg/m² on Day 1, 5-FU 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5.
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600 mg/m²/day intravenous
60 mg/m² or 75 mg/m² intravenous
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Time to progression
Periodo de tiempo: Throughout the study period
|
Throughout the study period
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Safety profile
Periodo de tiempo: Throughout the study period
|
Throughout the study period
|
Overall survival
Periodo de tiempo: From beginning to end of study
|
From beginning to end of study
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Tumor response
Periodo de tiempo: every 8 weeks
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every 8 weeks
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Clinical toxicities/symptomatology
Periodo de tiempo: Throughout the study period
|
Throughout the study period
|
Laboratory toxicities/symptomatology
Periodo de tiempo: Throughout the study period
|
Throughout the study period
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Martin Thoenes, Sanofi
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
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias
- Neoplasias por sitio
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Estómago
- Neoplasias de Estómago
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Docetaxel
- Cisplatino
- Fluorouracilo
Otros números de identificación del estudio
- DOCET_L_02195
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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