Clinical trial NCT01640782 (phase 3, status: completed)
Conditions: adenocarcinoma of the stomach, adenocarcinoma of the gastroesophageal junction
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: irinotecan, leucovorin, 5-fluorouracil, docetaxel, cisplatin, leucovorin, 5-fluorouracil
SMILES: FC1=CNC(=O)NC1=O, FC1=CNC(=O)NC1=O
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