Docetaxel in Locally Advanced Gastric Adenocarcinoma

Study Overview
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Brief Summary
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Study objectives: To determine Ro resection rate of Docetaxel, cisplatin and fluorouracil combination for the treatment of neoadjuvant gastric carcinoma.

Official Title
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Docetaxel, Cisplatin and Fluorouracil Combination in the Neoadjuvant Treatment of Locally Advanced Gastric Adenocarcinoma : Phase II Clinical Study

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Cisplatin
* Drug: Fluorouracil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven gastric adenocarcinoma diagnosis Selected Stage IIB (T3N0M0), Stage IIIA (T2aN2M0, T2bN2M0, T3N1M0, T4N0M0), Stage IIIB (T3N2M0) and selected Stage IV (all T4 , NM0, all TN3M0's). Clinical staging performed with endoscopic ultrasound and CT. Laparotomy or laparoscopy is preferred to determine resectability and peritoneal involvement. ECOG performance status between 0 and 2 Acceptable hematological profile : WBC (White Blood Cell) count ≥4000/mm3 Platelet count ≥100 000 mm3 Hemoglobin ≥9 g/100 mL (if lower, may be included following transfusion) Adequate renal function Serum creatinine <1.2 mg/dl or calculated creatinine clearance in 24-hours urine >60 mL/min. Adequate hepatic function Bilirubin < UNL Transaminases (ALT, AST) <2.5 x UNL Alcaline phosphatase <2.5 x UNL Adequate pulmonary function Adequate cardiac function No prior chemotherapy for gastric cancer Exclusion Criteria: Other histological types of gastric cancer (leiomyosarcoma, lymphoma) than adenocarcinoma Pregnant or lactating patients Patients with brain, bone or other metastases; peritoneal involvement Other serious underlying medical conditions which could impair the ability of the patient to participate in the study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus, serious neuropathy), history of myocardial infarction within 6 months prior to study entry Previous or other current malignancies, with the exception of carcinoma of the cervix uteri or breast cancer or basal cell skin cancer and a disease-free period shorter than 5 years Active infection and other serious disease Any other experimental drugs within a 4-week period prior to the study Contraindications for the use of any study drug (e.g. history of hypersensitivity to the contents of the study drugs) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel/Cisplatin/Fluorouracil (DCF)<br>DCF combination for three 21-day cycles unless a disease progression is observed at the tumor assessment scheduled after the second cycle or due to patient intolerability | Drug: Docetaxel<br>* Formulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 75 mg/m2<br>Drug: Cisplatin<br>* Formulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 75 mg/m2<br>Drug: Fluorouracil<br>* Formulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 750 mg/m2/day for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the R0 resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, Cisplatin, Fluorouracil combination. |  | 3 cycles |