Clinical trial: Evaluation of Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma (NCT01717924)

Eligibility criteria:
Inclusion Criteria:

          -  adenocarcinoma of the stomach or the oesogastric junction of type III of Siewert
             classification,histologically proven with the presence of signet ring cells (according
             to WHO 2000 classification) or diffuse form (according to Lauren classification) on
             pre-therapeutic biopsies

          -  tumoural stage IB, II or III (according to UICC-AJCC 2009)

          -  patient judged resectable in a curative intent on inclusion

          -  absence of distant metastasis

          -  absence of peritoneal carcinomatosis during pre-treatment explorative laparoscopy

          -  WHO performance status 2 or less

          -  age over 18 or under 80 years

          -  weight loss at the time of inclusion < 15%

          -  neutrophilic polynuclears more than 1500/mm3

          -  platelets more than 100000/mm3

          -  creatinine clearance more than 50 ml/min

          -  serum-albumin more than 30 gram/l

          -  bilirubin less than 1,5 normal

          -  prothrombin rate over 80%

          -  absence of prior treatment with chemotherapy or radiotherapy for gastric cancer

          -  absence of kniwn child B or C cirrhosis

          -  left ventricular ejection fraction more than 50% before epirubicin treatment

          -  extension check-up performed within 4 weeks of inclusion

          -  signed written informed consent given by the patient

        Exclusion Criteria:

          -  no corresponding to the inclusion criteria

          -  another malignant tumour treated for curative purposes during the past 5 years
             excepted basocellular skin carcinoma or in situ uterine cervix cancer

          -  allergy to the active substance or one of the excipients in the study drugs

          -  pregnancy or breast-feeding

          -  any other concommitant treatment, immunotherapy or hormonal therapy

          -  history of abdominal or chest radiotherapy

          -  any evolving disorder which is not under control (liver failure, kidney failure,
             respiratory failure, evolving heart failure or myocardial necrosis during the past 6
             months)

          -  patients who cannot be regularly monitored
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 80 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? 1