Peri-operative Chemotherapy With ECX or XP in the Treatment of Advanced Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and the effect of perioperative chemotherapy in the treatment of advanced gastric cancer.

Detailed Description
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To evaluate the security and the relapse-free survival time/rate(1,2,3 yrs) of perioperative chemotherapy with ECX (epirubicin + cisplatin + capecitabine) and XP (capecitabine + cisplatin）in advanced gastric cancer

Official Title
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Peri-operative Chemotherapy With ECX (Epirubicin + Cisplatin + Capecitabine) or XP (Capecitabine + Cisplatin) in the Treatment of Advanced Gastric Cancer: a Randomized, Multicenter, Parallel Control

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Peri-operative chemotherapy of ECX
* Drug: Peri-operative chemotherapy of XP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female aged 18 to 70 years old. The preoperative evaluation: gastric cancer patients, ≥ T2 or N +; or staging II, IIIA, IIIB. Karnofsky score ≥ 70, life expectancy > 6 months. Endoscopic biopsy diagnosis of gastric cancer, excluding non-Hodgkin's lymphoma, leiomyosarcoma and other mesenchymal tumors. the blood and biochemical indicators of the subjects must meet the following criteria: Hb ≥ 9 g / dl; WBC ≥ 4,000 / mm3, ≤ 12000 / mm3; PLT ≥ 100,000/mm3; GOT, GPT within twice the institutional limit,serum total bilirubin < 1.5 times the upper limit of normal, serum creatinine< 1.25 times the upper limit of normal and creatinine clearance rate ≥ 60ml/min, LVEF ≥ 60%. have not received prior chemotherapy, radiotherapy and biological therapy. signed informed consent. must accept the standard D2 or D2 + radical gastrectomy. with good compliance. Exclusion Criteria: pregnancy, breast-feeding women. allergy with chemotherapy drugs or metabolic disorder. the history of organ transplants (including bone marrow transplantation and autologous peripheral stem cell transplantation). had long received systemic steroid treatment (Note: short-term users of withdrawal > 2 weeks can be selected.) The existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders. patients with severe infection requires treatment. patients associated with dysphagia, active peptic ulcer, incompleteness intestinal obstruction, active gastrointestinal bleeding, perforation. severe liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrollable diabetes. with other malignancies which were not cured. EKG abnormalities or heart disease with apparent clinical symptoms, including congestive heart failure, coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction. Coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chemotherapy with ECX<br>chemotherapy with ECX | Drug: Peri-operative chemotherapy of ECX<br>* Preoperative chemotherapy of ECX for 3 cycles(Epirubicin 50mg/m2 on day 1; capecitabine 1000mg/m2, 2 times / day, 1 to 14 days; cisplatin 60mg/m2 on day 1, need hydration, 21 day/cycle), operation after 2 4 weeks, and postoperative chemotherapy of ECX for 3 cycles 4 6 weeks after surgery.<br>* Other names: ECX chemotherapy;|
| Experimental: chemotherapy with XP<br>chemotherapy with XP | Drug: Peri-operative chemotherapy of XP<br>* Preoperative chemotherapy of XP for 3 cycles(capecitabine 1000mg/m2, 2 times / day, 1 to 14 days; cisplatin 60mg/m2 on day 1, need hydration, 21 day/cycle), operation after 2 4 weeks, and postoperative chemotherapy of XP for 3 cycles 4 6 weeks after surgery.<br>* Other names: XP chemotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the relapse-free survival time/rate |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, Peri-operative chemotherapy