Clinical trial: Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer (NCT00718913)

Eligibility criteria:
Inclusion Criteria:

          -  Patients with radically resected adenocarcinoma of the stomach and/or gastroesophageal
             junction with histologic proof of adenocarcinoma, pathologically staged T2-3, any N,
             M0

          -  No prior radiation therapy to the stomach or immunotherapy or chemotherapy for any
             reason

          -  Patients must have a life expectancy of at least 16 weeks and a performance status of
             < 2 ECOG scale

          -  Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen.
             Patients who relapse within the first 6 months after the completion of adjuvant
             treatment are not eligible for the study.

          -  Patients must have adequate bone marrow function (defined as peripheral absolute
             granulocyte count of > 2.000/µL, and platelet count of > 100.000/µL), adequate liver
             function (bilirubin < 1,5 mg/dl), and adequate renal function (creatinine < 1,5 mg/dl

          -  Patients must be able to understand the nature of this study and give written informed
             consent

        Exclusion Criteria:

          -  Patients with T1N0 carcinoma

          -  Positive cytology of pleural, or pericardial effusion or patients with any peritoneal
             disease diagnosed intra-operatively)

          -  Biopsy proof of lymph node metastases outside the study field such as supraclavicular,
             mediastinal, or para-aortic nodes

          -  Evidence of metastatic disease to distant organs

          -  Patients with cardiac disease graded as New York Heart Association Class III or IV,
             severe uncontrolled diabetes, hypertension, cerebron-vascular disease, or infection

          -  Patients with diabetic neuropathy

          -  Abnormalities of mental status such that either the patient cannot fully comprehend
             the therapeutic implications of the protocol or comply with the requirements

          -  Presence of concurrent or previous malignancies in the past 5 years (except for
             resected squamous or basal cell carcinoma of the skin)

          -  Pregnant women are excluded from study entry due to the teratogenic effects of the
             study treatment
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.


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