Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Clinical Study

Study Overview
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Brief Summary
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The purpose of this study is to assess the relationship of pCR rate and efficacy by comparing the two drugs and three drugs as neoadjuvant chemotherapy in advanced gastric cancer patients.

Detailed Description
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Eligible patients will be randomly assigned by a randomisation system in a 1:1:1 ratio to three group. The group A wil receive four cycles of DOX (docetaxel 60mg/m2 on day 1,oxaliplatin 130mg/m2 on day 1 and capecitabine 1,000 mg/m2 per day on days 1 to 14, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.The group B wil receive four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox as adjuvant therapy.The group C wil receive eight cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.

Official Title
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Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Multicenter, Open, Randomized, Controlled Clinical Study

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: docetaxel,0xaliplatin,capecitabine
* Drug: oxaliplatin,capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically proven in operable advanced gastric adenocarcinoma; Subjects who were identified as potentially resectable cases by a multidisciplinary consultation; KPS> 80; ECOG score: 0-1; Expected survival> 6 months; Age 20 -60; Major organ function has to meet the following criteria: Neutrophil count ≥1.5 × 109 / L, platelet count ≥100 × 109 / L, Hemoglobin ≥90g / L, liver function <1.5 times the upper limit of normal, serum bilirubin ≤1.0 × UNL, serum creatinine <1.5 × UNL, PT-INR / PTT <1.7 times the upper limit of normal; Subjects has to voluntarily join the study and sign the Informed Consent Form for the study; Exclusion Criteria: Associated with serious diseases in liver ,kidney, cardiovascular system and other vital organs; History of hypersensitivity to docetaxel, capecitabine, oxaliplatin or the ingredients of this product; Receiving any form of chemotherapy or other study medication; Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method; Associated with inability to swallow, haemorrhagic peptic ulcer, mechanical or paralytic ileus, gastrointestinal active bleeding.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A（DOX）<br>Interventions：This arm wil receive four cycles of DOX (docetaxel 60mg/m2 on day 1,oxaliplatin 130mg/m2 on day 1 and capecitabine 1,000 mg/m2 per day on days 1 to 14, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy | Drug: docetaxel,0xaliplatin,capecitabine<br>* docetaxel 60mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14; oxaliplatin 130mg/m2， ivgtt，2h，d1;q21d<br>* Other names: AISU,AIHENG,AIBIN;|
| Active Comparator: B（Xelox）<br>Interventions：This arm wil receive four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox as adjuvant therapy | Drug: oxaliplatin,capecitabine<br>* oxaliplatin 130mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14;q21d<br>* Other names: AIHENG,AIBIN;|
| Active Comparator: C（Xelox）<br>Interventions：This arm wil receive eight cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy. | Drug: oxaliplatin,capecitabine<br>* oxaliplatin 130mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14;q21d<br>* Other names: AIHENG,AIBIN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pathological complete response rate |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival(OS) |  | 3 years | 
| Progression-free survival(PFS) |  | 3 years | 
| Disease-free survival(DFS) |  | 3 years | 
| Adverse events | Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resectable advanced gastric cancer