Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone as First Line Treatment for Patients With Advanced Adenocarcinoma of Stomach or Esophagogastric Junction

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether Taxanes or Platinum Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.

Official Title
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A Randomized Multicenter Phase III Study:Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone vs.Taxanes or Platinum Combined With Capecitabine in Advanced Adenocarcinoma of the Stomach or Esophagogastric Junction.

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Capecitabine
* Drug: capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having signed informed consent Age≥ 18 years old Histologically confirmed gastric adenocarcinoma Unresectable recurrent or metastatic disease Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months Previous chemotherapy with oxaliplatin or cisplatin or paclitaxel or docetaxel, if applicable, more than 12 months. Measurable disease according to the RECIST criteria ECOG performance status ≤2 Life expectancy of ≥3 month No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks ALT and AST≤2.5 times ULN (≤5 times ULN in patients with liver metastases) Serum albumin level ≥3.0g/dL Serum creatinine ≤1.5ULN Bilirubin level ≤ 1.5 ULN WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>90,000/mm3, Hb>8g/dl Exclusion Criteria: Brain metastasis (known or suspected) Previous systemic therapy for metastatic gastric cancer Inability to take oral medication Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Allergic constitution or allergic history to any investigating agents. Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension. Pregnancy or lactation period Any investigational agent within the past 28 days Other previous malignancy within 5 year Pre-existing neuropathy>grade 1 Legal incapacity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Taxanes or Platinum in combination with Capecitabine<br>The patients will received chemotherapy combining capecitabine with platinum or taxanes until progression. | Drug: Capecitabine<br>* 900-1000mg/m2 bid, days 1-14, every 3 weeks<br>|
| Experimental: chemotherapy followed by capecitabine alone<br>The patients who has received 4 cycle chemotherapy combining capecitabine with platinum or taxanes and the result was SD or CR or PR,will be given capecitabine alone until progression. | Drug: capecitabine<br>* Dosing schedule: 900-1000mg/m2 bid, days 1-14, every 3 weeks Maintenance dosing schedule: 1000-1250mg/m2 bid, days 1-14, every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response rate |  | 1 year | 
| disease control rate |  | 1 year | 
| overall survival |  | 3 year | 
| adverse events |  | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Cancer, capecitabine, maintenance treatment