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Spots Global Cancer Trial Database for Efficacy and Safety of Trastuzumab, Capecitabine y Oxaliplatine as Treatment Gastric Cancer Metastatic (HER2)Positive

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Fernando Rivera NA, Doctor

Affiliation: Sponsor represntative

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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