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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
316
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.
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.
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.
Time to disease progression
Time frame: Up to approximately 7.3 years
Objective tumor response rate
Time frame: Up to approximately 7.3 years
Overall survival
Time frame: Up to approximately 7.3 years
Duration of response
Time frame: Up to approximately 7.3 years
Time to response
Time frame: Up to approximately 7.3 years
Incidence of adverse events
Time frame: Up to approximately 7.3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Rosario, Argentina
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Tegucigalpa, Belize
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Barretos, Brazil
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Curitiba, Brazil
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Florianópolis, Brazil
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Fortaleza, Brazil
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Porto Alegre, Brazil
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São Paulo, Brazil
...and 35 more locations