Clinical trial: Fluorouracil, Cisplatin, Leucovorin Calcium, and Cetuximab in Treating Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction (NCT01360086)

Eligibility criteria:
DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction

               -  Stage IB, II, or III disease according to TNM classification OR type I, II, or
                  III disease according to Siewert classification

                    -  TNM: T1N1-3, T2N0-3, T3N0-3, or T4N0-3 (no T1N0 or M1)

               -  Disease considered operable with curative intent

          -  No gastric scirrhous carcinoma (linitis plastica)

               -  Forms with independent cells are not considered linitis

          -  Measurable disease according to RECIST V1.1

          -  No planned esophagectomy without thoracotomy in patients with adenocarcinoma of the
             gastroesophageal junction type I

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-2

          -  Polynuclear neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Creatinine clearance > 50 mL/min

          -  Bilirubin < 1.5 times normal

          -  Serum albumin > 30 g/L

          -  Prothrombin time ≥ 80%

          -  FEV1 > 1 L in case of thoracotomy

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No known cirrhosis

          -  No other progressive condition that has not been stabilized including the following:

               -  Hepatic failure

               -  Renal failure

               -  Respiratory failure

               -  NYHA class III-IV congestive heart failure

               -  Unstable angina

               -  Myocardial infarction in the past 6 months

               -  Significant arrhythmias in the past 12 months

          -  No recent weight loss exceeding 15%

          -  No interstitial pneumonia

          -  No other malignant tumor within the past 5 years except for basal cell skin carcinoma
             or cancer in situ of the cervix

          -  No psychological, familial, or geographical reasons that will preclude the patient
             being monitored regularly

          -  No persons deprived of liberty or under guardianship (Disability Act)

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior chemotherapy or radiotherapy for gastric cancer

          -  No other concurrent anticancer treatment, immunotherapy, or hormone therapy

          -  No prior abdominal or thoracic radiotherapy
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