Phase II Multicenter Study in the Preoperative Treatment of Gastric Adenocarcinoma Consisting of Chemotherapy Using Docetaxel-cisplatin-5FU + Lenograstim Followed by Chemoradiation Based 5FU and Oxaliplatin
Inclusion Criteria:
- Male or female patients, Age: 18 to 65
- ECOG performance status of ≤ 1
- Histological documentation of the gastric adenocarcinoma. An extension will be
admitted to the omentum
- Adenocarcinoma of the stomach according to staging classification TNM Scannographic:
T2bN0, T2bN1, T3NO T3N +, T4N0, and T4N + M0 (cardia, Siewert II, III, fundus, body,
antrum) performed by ultrasonography and CT Scan. Optional : laparoscopy
- A positive peritoneal cytology is not a disqualifying factor if there is no
macroscopic carcinomatosis
- Absence of previous abdominal irradiation above the 5th sacral vertebra (in the
liver, pancreas, spleen, or mediastinal lodge)
- Loss of weight less than 15% over the base weight before diagnosis
- No psychological, familial, sociological or geographical condition that may affect
compliance and adherence to treatment, patient monitoring or understanding of the
study.
- Signed informed consent obtained before any study specific procedures.
- Food Consumption> 1000 calories / day whatever the mode of administration (enteral or
parenteral)
- Laboratory test conducted within one week of starting to study treatment:
- Absolute neutrophil count > 1500/mm3
- Platelet count > 100 000/mm3
- Total bilirubin <2 mg/dL
- Serum creatinine <13 mg/dL or creatinine clearance > 40 ml/min
- Hemoglobin (Hgb) ≥ 10 g/dL (Hemoglobin transfusion if necessary)
- ALT / AST <1.5 x ULN
- PTT ≥ 60 %
- Life expectancy of at least 3 months
Exclusion Criteria:
- Peripheral sensory neuropathy ≥ grade 1 (according to CTCAE version 3.0).
- Myocardial infarction, stroke or pulmonary embolism, unstable angina less than 6
months before start of study drug.
- Uncontrolled infection
- Pregnant or breast-feeding patients. Women of childbearing potential must have a
pregnancy test performed.
- Prior treatment for gastric adenocarcinoma
- Lower limbs arteritis (≥ stage II according the Leriche and Fontain classification)
- Patient participating in another clinical trial or already receiving other
anti-cancer treatment
- Concomitant treatment with a phenytoin
- Known previous / current malignancy within the last 5 years except for non-melanoma
skin, non-metastatic prostate carcinoma and cervival carcinoma in situ or superficial
bladder carcinoma.