Clinical trial: A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma (NCT02301481)

Eligibility criteria:
Inclusion Criteria:

          -  Histologically or cytologically proven locally advanced gastric adenocarcinoma in
             patients staged as cT3-4N0M0 or anyTN+M0

          -  No distant metastasis in liver,lung,bone,central nervous system(CNS),no peritoneal
             transplantation

          -  No prior abdominal or pelvic radiotherapy

          -  Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months

          -  Patients must have normal organ and marrow function as defined below: Leukocytes:
             greater than or equal to 3,000 G/L; Platelets: greater than or equal to 100,000/mm3
             .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal
             institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit;
             Creatinine within normal upper limits

          -  Informed consent

        Exclusion Criteria:

          -  Any prior chemotherapy or other cancer treatment prior to this protocol

          -  Patients with other cancer history except cervical carcinoma in situ and non-malignant
             melanoma skin cancer

          -  With any distant metastasis in liver,lung,bone,CNS,or peritoneal transplantation

          -  History of allergic reactions attributed to similar chemical or biologic complex to
             S-1 or Xeloda or Oxaliplatin

          -  Uncontrolled illness including, but not limited to, active infection, symptomatic
             heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness

          -  History of myocardial infarction within the past 6 months or history of ventricular
             arrhythmia

          -  History of prior radiation to the abdomen

          -  Pregnant or lactating females
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 75 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