Clinical trial: NESC: Neoadjuvant Treatment Of Gastric Adenocarcinoma (NCT01565109)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment