Stage IV Gastric Cancer With Metastasis Clinical Trial
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.
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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