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Brief Title: Efficacy and Safety of Trastuzumab, Capecitabine y Oxaliplatine as Treatment Gastric Cancer Metastatic (HER2)Positive
Official Title: Phase II Study to Assess the Efficacy and Safety of Trastuzumab in Combination With Xelox as First-line Treatment of Patients With Advanced or Metastatic Gastric Cancer or Gastro-esophageal Junction, (HER2)-Positive.
Study ID: NCT01503983
Brief Summary: The objective of the study is assess the efficacy and safety of Trastuzumab in combination with Capecitabine+Oxaliplatin as first-line treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction, (HER2)-positive.
Detailed Description: Gastric cancer worldwide is the second tumor incidence (10%). There are significant geographical differences in Spain with an incidence of 15 cases/100,000 per year. Although the incidence and mortality of gastric cancer (GC) have experienced a marked reduction in the past 40 years, this disease remains a leading cause of cancer-related mortality, accounting for more than 870,000 deaths worldwide in the year 2000. Gastric cancer has a high mortality rate because usually diagnosed when in advanced stage and in many cases has a high relapse rate. Advanced gastric cancer cases are considered to be diagnosed with unresectable disease, either by having locally advanced disease (30% of cases at diagnosis), or having metastatic disease (another 30%) and patients with relapses (60% of resected). Thus, overall around 84% of patients with gastric cancer will have advanced disease. The only curative treatment so far is surgery. Thanks to early detection and implementation of appropriate surgical techniques, survival has improved in some countries such as Japan and Korea, being the rate of 5-year survival of 47%Over the years, a large number of studies with a single agent chemotherapy has been shown that gastric cancer is a relatively sensitive to chemotherapy. Based on these observations, the trend was the investigation of the combination of chemotherapy agents. Based on these results FDA and EMEA has approved capecitabine in the treatment of advance gastric cancer combined with platinum.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Lucus Augusti de Lugo, Lugo, A Coruña, Spain
Hospital Provincial de Pontevedra, Pontevedra, Vigo, Spain
Hospital Juan Canalejo, A Coruña, , Spain
Centro Oncológico de Galicia, A Coruña, , Spain
Hospital de Basurto, Bilbao, , Spain
Hospital Arnau de Vilanova de LLeida, Lleida, , Spain
Hospital Gregorio Marañon, Madrid, , Spain
Hospital La Paz, Madrid, , Spain
Hospital de Orense, Orense, , Spain
Hospital Universitario Cnetral de Asturias, Oviedo, , Spain
Hospital Universitario Marqués de Valdecilla, Santander, , Spain
Hospital Xeral Cies, Vigo, , Spain
Hospital de POVISA, Vigo, , Spain
Name: Fernando Rivera NA, Doctor
Affiliation: Sponsor represntative
Role: PRINCIPAL_INVESTIGATOR