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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Trastuzumab: 8 mg/kg day 1 followed by 6 mg/kg every 3 weeks (i.v.)
Capecitabine: 1000 mg/m2/12h/days 1 - 14 every 3 weeks (v.o.)
Oxaliplatin: 130 mg/m2 in 2 h, day 1 / (i.v.) /every 3 weeks
Hospital Juan Canalejo
A Coruña, A Coruña, Spain
Centro Oncológico de Galicia
A Coruña, A Coruña, Spain
Hospital Lucus Augusti de Lugo
Lugo, A Coruña, Spain
Overall Survival
Overall survival defined as the time from start of treatment until the patient's death
Time frame: up to 10 Months
progression free survival
Progression free survival defined as time from start of treatment until date of progression were observed according to RECIST 1.1
Time frame: 5 months
the time to progression
Time to progression defined as time elapsed since the beginning of treatment until disease progression
Time frame: 5 months
duration of response
Duration of response defined as the time since the objective complete or partial response until there is disease progression
Time frame: 10 months
time to response
Time to response, defined as the time from initiation of treatment until objective complete or partial response
Time frame: 10 months
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Bilbao, Bilbao, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Arnau de Vilanova de LLeida
Lleida, Lleida, Spain
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Madrid, Madrid, Spain
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...and 3 more locations