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| ID | Type | Description | Link |
|---|---|---|---|
| H 0406127 007 | Other Identifier | Seoul National University Hospital |
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The role of perioperative chemotherapy in potentially operable advanced gastric cancer (AGC) with regional lymph node metastasis is still in the area of controversy. The aim of this study is to evaluate the efficacy and toxicity of folinic acid (FA), infusional 5-fluorouracil (5-FU), and oxaliplatin (modified FOLFOX6) in potentially resectable AGC with regional lymph node (LN) metastasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mFOLFOX6 | 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, which is 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mFOLFOX6 (folinic acid, 5-fluorouracil, and oxaliplatin ) | 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, which is 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 |
|---|---|---|
| clinical response rate as assessed using RECIST criteria, with computed tomography (CT) scans at baseline and after 4cycles of chemotherapy | 4 cycles of chemotherapy (expected average of 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | From date of study enrollment until the date of first documented progression, assessed up to 60 months | |
| overall survival | From date of study enrollment until the date of first documented progression, assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| gene expression profile | after 4 cycles of chemotherapy (expected average of 8 weeks) | |
| early metabolic response by PET-CT | 2 cycles of chemotherapy (expected average of 4 weeks) | |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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|
| Pharmacologic Genetic Marker |
| 4 cycles of chemotherapy (expected average of 8 weeks) |
| ID | Term |
|---|---|
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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