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Spots Global Cancer Trial Database for Pre-Operative Or Peri-Operative Dox Regimen In Patients With Locally Advanced Resectable Gastric Cancer

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Trial Identification

Brief Title: Pre-Operative Or Peri-Operative Dox Regimen In Patients With Locally Advanced Resectable Gastric Cancer

Official 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

Study ID: NCT01876927

Study Description

Brief Summary: 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

Detailed Description: 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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - GM Lancisi, Ancona, AN, Italy

USL 8 Arezzo - Presidio Ospedaliero Zona Casentino - Ospedale di Bibbiena, Bibbiena, AR, Italy

USL 8 Arezzo - Ospedale "Santa Maria alla Gruccia", Valdarno (Montevarchi), AR, Italy

UO Oncologia , Spedali Civili di Brescia, Brescia, BS, Italy

Ospedale Bufalini, Cesena, FC, Italy

UO oncologia medica IRCCS IRST, Meldola (FC), FC, Italy

UOC Oncologia , Azienda USL 11, Empoli, FI, Italy

Ospedale Careggi, Firenze, FI, Italy

UO ONCOLOGIA , Istituto Europeo di Oncologia, Milano, MI, Italy

Istituto Clinico Humanitas, Rozzano, MI, Italy

Azienda Ospedaliera Universitaria Pisana, Pisa, PI, Italy

UO Oncologia, Fondazione Policlinico San Matteo, Pavia, PV, Italy

UO Oncologia Medica, PO Rimini, AUSL della Romagna, Rimini, RI, Italy

UO Oncologia , Casa di Cura Tortorella, Salerno, SA, Italy

Policlinico Le Scotte, Siena, SI, Italy

UO Oncologia, Azienda Ospedaliero Treviglio, Treviglio, TV, Italy

UO Oncologia Medica, azienda Ospedaliera di Varese, Varese, VA, Italy

Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia, Perugia, , Italy

Ospedale San Filippo Neri, Roma, , Italy

Ospedale Borgo Trento, Verona, , Italy

Contact Details

Name: Manlio Monti, MD

Affiliation: IRST IRCCS, Meldola

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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