Clinical trial: Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach (NCT01640782)

Eligibility criteria:
Inclusion Criteria:

          -  Histologically proven adenocarcinoma of the stomach or gastroesophageal junction
             without gross or microscopic evidence of residual disease after surgery with curative
             intent;

          -  Subtotal or total gastrectomy with at least D1 dissection;

          -  Gastroesophageal junction adenocarcinoma extending to the stomach with the center
             lying 2 to 5 cm below the anatomic esophago-gastric junction;

          -  Patients with nodal involvement (pN+) or patients without nodal involvement (pN0) with
             pT2b-3-4. It is recommended to examine at least 15 lymph nodes;

          -  Age between 18 and 75 years;

          -  ECOG performance status 0-1;

          -  No previous chemotherapy and/or radiotherapy;

          -  Complete staging procedures within 3 months prior to randomization;

          -  Laboratory requirement (within 8 days prior to randomization):

               -  Haematology (Neutrophils > 2.0 x 109 /L, Platelet > 100 x 109 /L, Hemoglobin >
                  10g/dL);

               -  Hepatic function (Total bilirubin < 1 UNL, ASAT (SGOT) and ALAT (SGPT) < 2.5xUNL,
                  Alkaline phosphatase < 2.5xUNL. Patients with ASAT or ALAT > 1.5xUNL associated
                  with alkaline phosphatase > 2.5XUNL are not eligible.)

               -  Renal function (Creatinine < 1.5 UNL. In presence of borderline values, the
                  calculated creatinine clearance according to Cockroft-Gault formula, 60 ML/min.

          -  Recovery from acute effects of surgery. The first infusion of study chemotherapy
             should be administered 3 to 8 weeks after surgery treatment;

          -  Written informed consent signed and dated before randomization procedures, including
             expected cooperation of the patients for the treatment and follow-up, must be obtained
             and documented according to the local regulatory requirement.

        Exclusion Criteria:

          -  Non-radical surgery as assessed microscopically (no tumor-free margin of resection,
             positive biopsy of peritoneal suspicious lesions);

          -  Synchronous metastases, even curatively resected;

          -  Pregnant or lactating patients; patients with reproductive potential must implement
             adequate contraceptive measures;

          -  Prior or concurrent history of:

               -  positive HIV serology,

               -  chronic diarrhoea,

               -  chronic bowel inflammation or subobstruction,

               -  neoplasm other than gastric cancer, except for: curatively treated non-melanoma
                  skin cancer, in situ carcinoma of the cervix,

               -  previous history of myocardial infarction within 1 year from study entry,

               -  hypersensitivity reaction to polysorbate 80;

          -  Presence of other systemic disease limiting drug administration and influencing
             patient survival:

               -  uncontrolled hypertension,

               -  high-risk uncontrolled arrhythmia,

               -  unstable angina pectoris;

          -  Symptomatic

               -  peripheral neuropathy,

               -  altered hearing > 2 grade by NCIC-CTG criteria;

          -  Active uncontrolled infection.

          -  Definite contra-indications for the use of corticosteroids: unstable diabetes
             mellitus, active peptic ulcer;

          -  Concurrent administration of:

               -  corticosteroids or equivalent except as use for the prophylactic medication
                  regimen, treatment of acute hypersensitivity reactions or unless chronic
                  treatment (initiated > 6 months prior to study entry) at low doses (< 20mg
                  methylprednisolone or equivalent);

               -  any other experimental drug under investigation: concurrent treatment with any
                  other anticancer therapy, growth factors with preventive intent
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? Entailment