A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer
NCT ID: NCT02563054
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
316 participants
INTERVENTIONAL
2003-04-30
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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5-Fluorouracil + Cisplatin
Participants will receive 5-FU in combination with cisplatin upto disease progression.
5-Fluorouracil
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.
Cisplatin
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.
Capecitabine + Cisplatin
Participants will receive capecitabine in combination with cisplatin upto disease progression.
Capecitabine
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
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.
Interventions
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5-Fluorouracil
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.
Capecitabine
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
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.
Eligibility Criteria
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Inclusion Criteria
* Advanced and/or metastatic gastric cancer with at least 1 measurable lesion
Exclusion Criteria
* Evidence of central nervous system (CNS) metastases
* History of other malignancy within the last 5 years, except cured basal cell cancer of the skin or cured in-situ cancer of the uterine cervix
* Radiation therapy or major surgery within 4 weeks of study drug
* Previous chemotherapy
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Buenos Aires, , Argentina
Buenos Aires, , Argentina
Rosario, , Argentina
Tegucigalpa, , Belize
Barretos, , Brazil
Curitiba, , Brazil
Florianópolis, , Brazil
Fortaleza, , Brazil
Porto Alegre, , Brazil
São Paulo, , Brazil
Sorocaba, , Brazil
Beijing, , China
Beijing, , China
Guangdong, , China
Guangdong, , China
Hubei, , China
Jiangsu, , China
Jiangxi, , China
Shandong, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Suzhou, , China
Tianjin, , China
Bogotá, , Colombia
Guatemala City, , Guatemala
Hong Kong, , Hong Kong
Hong Kong, , Hong Kong
Kuala Lumpur, , Malaysia
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mérida, , Mexico
Panama City, , Panama
Callao, , Peru
Lima, , Peru
Kazan', , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Ufa, , Russia
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Montevideo, , Uruguay
Countries
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References
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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.
Other Identifiers
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ML17032
Identifier Type: -
Identifier Source: org_study_id