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This study is to evaluate the antitumor activity (i.e. progression free survival, overall survival, response rate, etc), safety and quality of life in patient with recurrent or metastatic gastric cancer during 4-regimen (i.e. SP, FL/Tax, FL/Doc, FOLFOX) based chemotherapy. In addition, it is to evaluate efficacy and adverse events of anticancer agents according to the results of pharmacogenetic study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP(S-1 with cisplatin) | Active Comparator | SP <Every 3 weeks>
|
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| FL/Tax(Paclitaxel with Leucovorin with 5-FU) | Active Comparator | FL/Tax <Every q 3 weeks>
|
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| FL/Doc(Decetaxel with Leucovorin with 5-FU) | Active Comparator | FL/Doc <Every q 3 weeks>
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| FOLFOX(Oxaliplatin with Leucovorin with 5-FU) | Active Comparator | FOLFOX <Every q 2 weeks> D1 : Oxaliplatin 100mg/m2 IVF for 2hours D1 : Leucovorin 20mg/m2 IVF for 1hour D1 : 5-FU 400mg/m2 IV bolus D1~2 : 5-FU 1200mg/m2 IVF for 24hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP | Drug | <Every 3 weeks>
|
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival(PFS) | Imaging assessments will be performed every 6 weeks until radiographically documented PD(Progressive Disease). | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Prior chemotherapy (however, previous (neo-)adjuvant chemotherapy allowed if finished at least 6month ago except S-1, Paclitaxel, Docetaxel, Oxaliplatin . Allowed 5-FU, Cisplatin if finished 6month ago)
Patients with oral intake is impossible or with malabsorption syndrome
Patients with medically uncontrolled severe complications or infection
Patients who have central nervous system disorders, mental disorders, or evidence of CNS metastases
Patient with diagnosed active overlapping cancer within the past 5years except adequately treated carcinoma insitu of the cervix, basal or squamous cell carcinoma of skin
The possibility(will) of pregnancy , or pregnant and lactating women
Patients with clinically significant heart disease
Progression of gastric lesions is not possible to evaluate
During clinical trials, patient receiving of systemic chemotherapy or other clinical trials drugs or radiotherapy (However, it is possible that palliative radiotherapy treatment for pain relief on primary lesion after more than 2 weeks)
Peripheral neuropathy of Grade 2 or greater.
Patients who taking drugs to change of pharmacological activity of S-1 medicine(Warfarin, phenytoin, allopurinol etc.). Except regular treatment of corticosteroids(or equivalent drugs). However, it is allowed the purposes for pre-treatment of study drugs and the control of nausea and vomiting. (However, it is allowed the treatment for acute allergic reactions, or the treatment with low doses (methylprednisolone 20mg or less, or the equivalent drug) from about 6 months)
Other cases
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005770 | Gastrointestinal Neoplasms |
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| ID | Term |
|---|---|
| C103828 | titanium silicide |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000077143 | Docetaxel |
| C410216 | Folfox protocol |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| FL/Tax | Drug | <Every q 3 weeks>
|
|
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| FL/Doc | Drug | <Every q 3 weeks>
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|
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| FOLFOX | Drug | <Every q 2 weeks> D1 : Oxaliplatin 100mg/m2 IVF for 2hours D1 : Leucovorin 20mg/m2 IVF for 1hour D1 : 5-FU 400mg/m2 IV bolus D1~2 : 5-FU 1200mg/m2 IVF for 24hours |
|
|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D043823 |
| Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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 |