Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer

Study Overview
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Brief Summary
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The objective of the trial is to compare Overall survival between capecitabine plus oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with advanced gastric cancer.

Official Title
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A Randomized, Phase III, Multicenter Clinical Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: XELOX
* Drug: XELODA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 70 Histologically or cytologically confirmed adenocarcinoma of the gastric Advanced ,metastatic/recurrence gastric cancer ECOG performance status of 0 to 2 Life expectancy≥3months No history of any systemic anti-cancer chemotherapy (prior adjuvant chemoradiation or chemotherapy is allowed if the last date of drug administration is > 6months from the study entry date) No history of radiation therapy about Target lesion. (Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization. Adequate marrow functions (ANC ≥ 1,500/uL, PLT ≥100,000/uL) Adequate renal functions (Creatinine ≤1.5mg/dL or Ccr ≥ 50ml/min) Adequate hepatic functions ( bilirubin ≤ 2.0mg/dL, SGOT/SGPT < normal x 3) provision of a signed written informed consent Exclusion Criteria: History of any medical or psychiatric condition Active infections Peripheral neuropathy with symptom(NCI-CTCAE ver. 3.0 >=Grade 1 ) symptomatic brain metastases Double primary cancer (physician at the discretion of the other cancer cured the purpose of early cancer cases can be registered) History of other malignancy except: Adequately treated non-melanomatous skin cancer or cervical carcinoma in situ Known hypersensitivity to Fluoropyrimidines/platinum Clinical significant cardiovascular disease (myocardial infarction, symptomatic coronary artery disease, congestive heart failure, severe arrhythmias) Required immunosuppressive therapy(transplant patients, severe autoimmune disease)

Ages Eligible for Study
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Minimum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: XELODA<br>Capecitabine 1000mg/m2 bid D1-14 every 3weeks | Drug: XELODA<br>* Capecitabine 1000mg/m2 bid D1-14 every 3weeks<br>|
| Experimental: XELOX<br>D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks | Drug: XELOX<br>* D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA) |  | 36months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | 36months |