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This is a Phase II Trial of Perioperative Chemotherapy with Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6)in Patients with Locally Advanced Operable Gastric Cancer.
The main purpose of this study is to evaluate response rate (clinical response and pathological response) of oxaliplatin, 5-fluorouracil, leucovorin(MODIFIED FOLFOX6)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified FOLFOX6 | Experimental | Modified FOLFOX6 regimen consists of oxaliplatin 100 mg/m2 and FA 100 mg/m2 given as a 2 hour intravenous infusion, followed by 5-FU 2.4 g/m2 given as a continuous infusion over 46 hour, repeated every 2 weeks. Patients receive 4 cycles of neoadjuvant modified FOLFOX6 followed by curative radical surgery with D2 dissection and 4 cycles of adjuvant modified FOLFOX6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MODIFIED FOLFOX6 | Drug | Modified FOLFOX6 regimen consists of oxaliplatin 100 mg/m2 and FA 100 mg/m2 given as a 2 hour intravenous infusion, followed by 5-FU 2.4 g/m2 given as a continuous infusion over 46 hour, repeated every 2 weeks. Patients receive 4 cycles of neoadjuvant modified FOLFOX6 followed by curative radical surgery with D2 dissection and 4 cycles of adjuvant modified FOLFOX6. |
| Measure | Description | Time Frame |
|---|---|---|
| response rate | response rate by the RECIST criteria | 22 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3-4 toxicity | toxicity : Grade 3-4 toxicity by the NCI-CTCAE v3.0 | one year |
| median overall survival | median value of the time from enrollment to the patient's death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seock-Ah Im, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | South Korea | ||||
| Seoul National University Hospital |
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|
| 1 year |
| median time to treatment failure | median value of the time from enrollment to disease progression, withdrawl of consent, or unacceptable toxicity | 1 year |
| resection rate | the rate of patients whose tumor was completely resected | 1 year |
| Seoul |
| South Korea |