The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Manlio Monti, MD
Affiliation: IRST IRCCS, Meldola
Role: PRINCIPAL_INVESTIGATOR