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We stop because of problems such as insurance.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XELODA | Active Comparator | Capecitabine 1000mg/m2 bid D1-14 every 3weeks |
|
| XELOX | Experimental | D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XELOX | Drug | D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA) | 36months |
| Measure | Description | Time Frame |
|---|---|---|
| response rate | 36months |
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Inclusion Criteria:
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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung medical Center | Seoul | 135-710 | South Korea |
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| XELODA | Drug | Capecitabine 1000mg/m2 bid D1-14 every 3weeks |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C519688 | XELOX |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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