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This study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus 5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at least 6 weeks and continued up to disease progression, and the target sample size is 300 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-Fluorouracil + Cisplatin | Active Comparator | Participants will receive 5-FU in combination with cisplatin upto disease progression. |
|
| Capecitabine + Cisplatin | Experimental | Participants will receive capecitabine in combination with cisplatin upto disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Fluorouracil | Drug | Participants will receive 5-FU, 800 milligrams per meter-squared (mg/m^2) per day via IV infusion during Days 1 to 5 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression | Up to approximately 7.3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response rate | Up to approximately 7.3 years | |
| Overall survival | Up to approximately 7.3 years | |
| Duration of response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | C1264AAA | Argentina | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29372626 | Derived | Chen J, Xiong J, Wang J, Zheng L, Gao Y, Guan Z. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin in Chinese patients with advanced and metastatic gastric cancer: Re-analysis of efficacy and safety data from the ML17032 phase III clinical trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e310-e316. doi: 10.1111/ajco.12832. Epub 2018 Jan 26. |
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| Capecitabine | Drug | Participants will receive oral capecitabine, 1000 mg/m^2 twice daily on Days 1 to 14 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression. |
|
| Cisplatin | Drug | Participants will receive cisplastin, 80 mg/m^2 via IV infusion on Day 1 of each 3-week cycle, for a total of 6 cycles or upto disease progression in combination with either capecitabine or 5-FU. |
|
| Up to approximately 7.3 years |
| Time to response | Up to approximately 7.3 years |
| Incidence of adverse events | Up to approximately 7.3 years |
| Buenos Aires |
| C1270AAE |
| Argentina |
| Rosario | S2000PBJ | Argentina |
| Tegucigalpa | Belize |
| Barretos | 14780-400 | Brazil |
| Curitiba | 80060-150 | Brazil |
| Florianópolis | 88034-000 | Brazil |
| Fortaleza | 60741-420 | Brazil |
| Porto Alegre | 90020-090 | Brazil |
| São Paulo | 05403-010 | Brazil |
| Sorocaba | 18035-300 | Brazil |
| Beijing | 100021 | China |
| Beijing | 100036 | China |
| Guangdong | 510060 | China |
| Guangdong | 510515 | China |
| Hubei | 430030 | China |
| Jiangsu | 210009 | China |
| Jiangxi | 330000 | China |
| Shandong | 250117 | China |
| Shanghai | 200003 | China |
| Shanghai | 200092 | China |
| Shanghai | 200433 | China |
| Suzhou | 215006 | China |
| Tianjin | 300060 | China |
| Bogotá | Colombia |
| Guatemala City | 01015 | Guatemala |
| Hong Kong | 852 | Hong Kong |
| Hong Kong | Hong Kong |
| Kuala Lumpur | 56000 | Malaysia |
| Mexico City | 06726 | Mexico |
| Mexico City | 14000 | Mexico |
| Mexico City | 14080 | Mexico |
| Mérida | 97070 | Mexico |
| Panama City | 83-0669 | Panama |
| Callao | Peru |
| Lima | 13 | Peru |
| Kazan' | 420029 | Russia |
| Moscow | 115478 | Russia |
| Saint Petersburg | 197758 | Russia |
| Ufa | 450054 | Russia |
| Seoul | 135-170 | South Korea |
| Seoul | 135-720 | South Korea |
| Seoul | 138-736 | South Korea |
| Seoul | 405-760 | South Korea |
| Montevideo | 11600 | Uruguay |
| 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 |
|---|---|
| D005472 | Fluorouracil |
| D000069287 | Capecitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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