RANDOMIZED PHASE II STUDY WITH SEQUENTIAL NON-CROSS RESISTANT CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED INOPERABLE OR METASTATIC GASTRO-ESOPHAGEAL ADENOCARCINOMA

INTERVENTION: Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: DOCETAXEL CAS Number: 114977‐28‐5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 10‐20 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: CALCIUM LEVOFOLINATE PENTAHYDRATE CAS Number: 80433‐71‐2 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 100‐175 Pharmaceutical Form: Solution for injection INN or Proposed INN: 5‐FLOUROURACIL CAS Number: 51‐21‐8 Other descriptive name: FLUOROURACIL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Pharmaceutical Form: Solution for infusion INN or Proposed INN: CISPLATIN CAS Number: 15663‐27‐1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: OXALIPLATIN CAS Number: 61825‐94‐3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5‐ Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: IRINOTECAN HYDROCHLORIDE TRIHYDRATE CAS Number: 136572‐09‐3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ CONDITION: Locally advanced inoperable or metastatic gastro‐esophageal adenocarcinoma ; MedDRA version: 17.0 Level: PT Classification code 10030144 Term: Oesophageal adenocarcinoma stage III System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 17.0 Level: PT Classification code 10001150 Term: Adenocarcinoma gastric System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 17.0 Level: PT Classification code 10030145 Term: Oesophageal adenocarcinoma stage IV System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] SECONDARY OUTCOME: Secondary end point(s): 1) Overall Response Rate – ORR; ; 2) Time To Progression ‐ TTP ; 3) Overall Survival ‐ OS; ; 4) Safety profile assessed on the base of laboratory and clinic parameters (hematology, biochemistry, ECOG‐PS) and on the evaluation of Adverse Events classified per type, frequency, seriousness (NCI, Common Terminology Criteria, Version 4.0 – CTCAE v.4.0), releted to study therapy, duration; ; 5) Quality of life evaluated through EORTC QLQ‐C30 questionnaire. ; Timepoint(s) of evaluation of this end point: 1‐2) From randomization date until desease progression at the following assessment points: at the end of induction period, every 8 weeks during treatment, at the end of treatment and every 8 weeks during follow up; ; 3) from randomization date to patient’s death for any cause or last date documenting the patient is alive, until 18 months from the date of evaluation of treatment end; ; 4)‐5) All study period including follow up. ; INCLUSION CRITERIA: 1. Histologic diagnosis for gastric or esophageal adenocarcinoma, stage III inoperable or IV; 2. Age > 18 years and < 75 years; 3. ECOG Performance Status (PS) =65 years) yes F.1.3.1 Number of subjects for this age range 90