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The purpose of the study is to verify non-inferiority of survival time between Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable advanced or recurrent gastric cancer. Secondary endpoints include response rates, duration of responses, time to progression (TTP) safety and quality of life (QOL).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isovorin | Drug | |||
| TS-1 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Survival time |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate, duration of response, time to progression, safety, quality of life |
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Inclusion Criteria:
Other inclusion applies
Exclusion Criteria:
Other exclusion applies
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adachi-ku, Tokyo | 123-0855 | Japan | ||||
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| Anjo |
| 446-8602 |
| Japan |
| Aomori | 030-8553 | Japan |
| Chiba | 260-8607 | Japan |
| Chiba | 260-8717 | Japan |
| Chikushino-shi | 818-8502 | Japan |
| Fukuoka | 812-8582 | Japan |
| Fukuroi-shi | 437-0061 | Japan |
| Funai-gun | 629-0392 | Japan |
| Hiroshima | 730-8619 | Japan |
| Hiroshima | 734-8551 | Japan |
| Ichihara-shi | 290-0003 | Japan |
| Kanagawa | 224-8503 | Japan |
| Kanazawa | 920-8641 | Japan |
| Kisaradu-shi | 292-8535 | Japan |
| Kitaadachi-gun | 362-0806 | Japan |
| Koto-ku, Tokyo | 135-8577 | Japan |
| Kyoto | 602-8566 | Japan |
| Misawa-shi | 033-0001 | Japan |
| Morioka | 020-8505 | Japan |
| Nagasaki | 852-8501 | Japan |
| Nagoya | 458-0037 | Japan |
| Nagoya | 464-8681 | Japan |
| Osaka | 537-8511 | Japan |
| Osaka | 545-8585 | Japan |
| Ōmura | 856-8562 | Japan |
| Saga | 840-8571 | Japan |
| Sagamiharashi | 228-8520 | Japan |
| Sapparo City | 064-0923 | Japan |
| Sapporo | 003-8585 | Japan |
| Sapporo | 060-0001 | Japan |
| Sapporo | 060-8543 | Japan |
| Sasebo-shi | 857-8511 | Japan |
| Sendai | 983-8512 | Japan |
| Sendai | 983-8520 | Japan |
| Shizuka | 432-8580 | Japan |
| Shizuoka | 420-8527 | Japan |
| Sizuoka-shi | 420-8623 | Japan |
| Takatuki-si | 569-8666 | Japan |
| Tsuchiura-shi | 300-0053 | Japan |
| Tsukuba | 305-8576 | Japan |
| Uji-shi | 611-0042 | Japan |
| Yamagata | 990-2292 | Japan |
| 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 |
|---|---|
| D002955 | Leucovorin |
| C103828 | titanium silicide |
| 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 |
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