Clinical trial: Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer (NCT00004099)

Eligibility criteria:
DISEASE CHARACTERISTICS:

          -  Histologically proven stage II-IV adenocarcinoma of the stomach including cardia
             carcinoma types II and III

               -  Locally resectable disease

               -  No distant metastases except M1 lymph nodes

               -  No evidence of peritoneal carcinomatosis

                    -  Free tumor cells in lavage at laparoscopy allowed

          -  No uncontrolled bleeding of the primary tumor

          -  No gastric outlet syndrome or complete tumor stenosis that would require total
             parenteral nutrition

        PATIENT CHARACTERISTICS:

        Age:

          -  18 to 69

        Performance status:

          -  WHO 0-1

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  WBC greater than 4,000/mm^3

          -  Absolute neutrophil count greater than 2,000/mm^3

          -  Platelet count greater than 100,000/mm^3

        Hepatic:

          -  Bilirubin no greater than 1.25 times upper limit of normal (ULN)

          -  Prothrombin rate at least 70%

        Renal:

          -  Creatinine no greater than 1.25 times ULN

          -  Creatinine clearance greater than 60 mL/min

        Cardiovascular:

          -  No prior atrial or ventricular arrhythmias

          -  No prior congestive heart failure

          -  No myocardial infarction within the past 6 months

        Other:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other prior or concurrent neoplasm except curatively treated nonmelanoma skin
             cancer or carcinoma in situ of the cervix

          -  No active infection

          -  No allergy to protocol drugs

          -  No dementia or significantly altered mental status

          -  No other serious medical condition that would prevent compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No filgrastim (G-CSF) within 48 hours prior to chemotherapy

        Chemotherapy:

          -  No prior chemotherapy

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior radiotherapy

        Surgery:

          -  See Disease Characteristics

          -  No prior stent implantation

          -  No prior laser therapy
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 69 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