Title: A randomised phase II study of pre-operative or peri-operative docetaxel, oxaliplatin, capecitabine (DOX) regimen in patients with locally advanced resectable gastric cancer.~Clinical Phase: II~Study Objectives:~Primary:~The percentage of patients receiving all the planned chemotherapeutic cycles.~Secondary:~Downstaging according to Recist criteria~pT1-3 vs pT0.~Safety: number of patients with grade 3-4 toxicity~The role of PET Scan as predictor of response~Curative vs palliative surgery~TTP~OS~Diagnostic correlation between the various staging methods~Possible correlations between CT scan, CT/PET, laparoscopy;~Molecular markers related to toxicity: DPYD, MTHFR, TS, XPD, ERCC1, XRCC1;~Molecular markers related to prognosis: TYMS, GSTP1, COX-2, RUNX3, methylation profile (Cox2, hMLH1, MGMT);~Molecular markers related to therapy response: TYMS, DPYD, MTHFR, OPRT, ERCC1, XRCC1/2/3, GSTP1, GSTM1, GSTT1, ABCB1, methylation profile (Cox2, hMLH1, MGMT), whole genome arrayCGH.~Study design:~Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up~Population:~Male or female, 18-75 years of age, with a diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach.~Sample Size: Planned sample size is 90 patients, 45 patients for each arm (p0=50%, p1=80%, alpha=0.05 (two sides), beta=0.2)~Treatment Plan:~Treatment will be administered for 4 and 2 cycles before surgery in arm A and B, respectively, and in arm B for a further 2 cycles after surgery unless progression or unacceptable toxicity occurs, or a patient refuses treatment. In such cases patients will go off treatment. 3-6 weeks after the end of the fourth (arm A) or second (arm B) preoperative cycle, patients will undergo surgery.~After surgery 3-6 weeks from surgery patients in arm B will receive 2 more cycles.~DOX: Docetaxel 35 mg/m2 day 1 and 8 Oxaliplatin 80 mg/m2 day 1 Capecitabine 750 mg/m2 x 2 daily for 2 weeks~Cycles repeated every 3 weeks~Evaluation criteria: Tumor assessment will be performed according to the RECIST criteria (version 1.1).~Duration of Study:~Overall study duration: 07/2010- 03/2017 Planned study duration per patient: 5 years
Study design:~Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up~Population:~Male or female, 18-75 years of age, with a diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach.~Sample Size: Planned sample size is 90 patients, 45 patients for each arm (p0=50%, p1=80%, alpha=0.05 (two sides), beta=0.2)~Treatment Plan:~Treatment will be administered for 4 and 2 cycles before surgery in arm A and B, respectively, and in arm B for a further 2 cycles after surgery unless progression or unacceptable toxicity occurs, or a patient refuses treatment. In such cases patients will go off treatment. 3-6 weeks after the end of the fourth (arm A) or second (arm B) preoperative cycle, patients will undergo surgery.~After surgery 3-6 weeks from surgery patients in arm B will receive 2 more cycles.~DOX: Docetaxel 35 mg/m2 day 1 and 8 Oxaliplatin 80 mg/m2 day 1 Capecitabine 750 mg/m2 x 2 daily for 2 weeks~Cycles repeated every 3 weeks~Evaluation criteria: Tumor assessment will be performed according to the RECIST criteria (version 1.1).~Duration of Study:~Overall study duration: 07/2010- 03/2017 Planned study duration per patient: 5 years