A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma
Taxotere-Cisplatin-5FU
+ Immediate surgery
Enfermedades del Sistema Digestivo+5
+ Neoplasias del sistema digestivo
+ Enfermedades Gastrointestinales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de noviembre de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Compare, by intention to treat analysis, feasibility and efficacy of 4 courses of docetaxel, cisplatin, and fluorouracil as preoperative or postoperative chemotherapy in patients with locally advanced operable gastric carcinoma. Evaluate the predictive values of some biological and molecular tumor parameters on response to chemotherapy, metastasis and survival in this patient population. OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to study center, tumor site (affecting the Z-line (cardia carcinoma Siewart II and III) vs rest of the stomach), and nodal status (positive vs negative). Patients are randomized to either preoperative chemotherapy followed by surgery (arm I) or surgery followed by postoperative chemotherapy (arm II). Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 4 hours on day 1, and fluorouracil IV continuously on days 1-14 every 3 weeks. Patients are evaluated after 2 courses and patients with progressive disease proceed to immediate surgery. Otherwise, treatment continues for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Between 3-5 weeks following day 1 of the last course of chemotherapy, patients undergo gastric resection. Arm II: Patients undergo immediate gastric resection. Beginning 3-6 weeks after surgery, patients receive 4 courses of docetaxel, cisplatin, and fluorouracil as in arm I. Quality of life is assessed before the first and third courses of chemotherapy, before and after surgery, and then at 1, 3, and 6 months. Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 240 patients (120 per arm) will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 240 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 75 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically confirmed locally advanced gastric carcinoma that is considered operable T3-4, Nx, M0 OR Tx, N+, M0 Lymph nodes considered positive by sonography should be at least 2 of the following: Round Echopoor Sharp borders At least 0.5 cm No distant metastases, including peritoneal carcinomatosis CT scan and peritoneal lavage mandatory PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin normal AST or ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Adequate renal function within limits to allow for treatment with cisplatin Cardiovascular: No unstable cardiac disease requiring treatment No congestive heart failure or angina pectoris even if medically controlled No significant arrhythmias No myocardial infarction within past 6 months Ejection fraction greater than 50% on cardiac sonography or MUGA scan Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy except basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix No grade 2 or greater peripheral neuropathy of any origin (e.g., alcohol, diabetic) No history of anaphylaxis No other serious concurrent illness or medical condition that would preclude study therapy No history of significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures) PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy for gastric carcinoma Chemotherapy: No other concurrent chemotherapy for gastric carcinoma Endocrine therapy: No concurrent endocrine therapy for gastric carcinoma Radiotherapy: No concurrent radiotherapy for gastric carcinoma Surgery: See Disease Characteristics Other: At least 30 days since prior treatment in a clinical trial No other concurrent experimental drugs No other concurrent anticancer therapy
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 3 ubicaciones
Hopital Cantonal Universitaire de Geneve
Geneva, SwitzerlandZentrum fuer Tumordiagnostikund Praevention
Sankt Gallen, Switzerland