Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and overall survival of the regimen of XELOX (Xeloda and oxaliplatin combination) in the patients with relapsed and refractory gastric cancer.

Detailed Description
-----------------
The result of treatment in relapsed and refractory gastric cancer is still not satisfactory. For the moment, the combination of 5-Fu and cisplatin is regularly used. Capecitabine and Oxaliplatin are new generation drugs of 5-Fu and cisplatin. The current study is to evaluate the efficacy and toxicity of this combination.

Official Title
-----------------
Phase II Study on Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: Capecitabine and Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 70 years Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma ECOG performance status ≤1 Measurable diseases according to the RECIST Relapse or refractory after the first-line chemotherapy Sign ICF,normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min). Exclusion Criteria: Relapse within 6 months after adjuvant chemotherapy which contained oxaliplatin Have used any of drugs in the regimen in first-line chemotherapy Pregnant or lactating women,serious uncontrolled diseases and intercurrent infection The evidence of CNS metastasis History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Received other chemotherapy regimen after metastasis Participated in other clinical trials.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combine Chemotherapy<br>XELOX(Xeloda and oxaliplatin combination) | Drug: Capecitabine and Oxaliplatin<br>* Capecitabine 1000mg/m2 Bid d1-14 Oxaliplatin 130mg/m2 d1 q3w<br>* Other names: XELOX(Xeloda and oxaliplatin combination);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | 2-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression and overall survival |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced gastric cancer, Response rate, Side effects, time to progression, overall survival