A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer
An Open-Label Randomized International Multi-Center Phase III Study of Capecitabine (Xeloda) in Combination With Cisplatin Versus FU/Cisplatin in Patients With Advanced and/or Metastatic Gastric Cancer
1 other identifier
interventional
316
14 countries
45
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 gastric-cancer
Started Apr 2003
Longer than P75 for phase_3 gastric-cancer
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
September 29, 2015
CompletedNovember 2, 2016
November 1, 2016
7.3 years
September 28, 2015
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Time to disease progression
Up to approximately 7.3 years
Secondary Outcomes (5)
Objective tumor response rate
Up to approximately 7.3 years
Overall survival
Up to approximately 7.3 years
Duration of response
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
Study Arms (2)
5-Fluorouracil + Cisplatin
ACTIVE COMPARATORParticipants will receive 5-FU in combination with cisplatin upto disease progression.
Capecitabine + Cisplatin
EXPERIMENTALParticipants will receive capecitabine in combination with cisplatin upto disease progression.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adults 18 to 75 years of age
- Advanced and/or metastatic gastric cancer with at least 1 measurable lesion
You may not qualify if:
- Uncontrolled infection
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Unknown Facility
Buenos Aires, C1264AAA, Argentina
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Buenos Aires, C1270AAE, Argentina
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Rosario, S2000PBJ, Argentina
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Tegucigalpa, Belize
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Barretos, 14780-400, Brazil
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Curitiba, 80060-150, Brazil
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Florianópolis, 88034-000, Brazil
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Fortaleza, 60741-420, Brazil
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Porto Alegre, 90020-090, Brazil
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São Paulo, 05403-010, Brazil
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Sorocaba, 18035-300, Brazil
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Beijing, 100021, China
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Beijing, 100036, China
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Guangdong, 510060, China
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Guangdong, 510515, China
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Hubei, 430030, China
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Jiangsu, 210009, China
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Jiangxi, 330000, China
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Shandong, 250117, China
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Shanghai, 200003, China
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Shanghai, 200092, China
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Shanghai, 200433, China
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Suzhou, 215006, China
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Tianjin, 300060, China
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Bogotá, Colombia
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Guatemala City, 01015, Guatemala
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Hong Kong, 852, Hong Kong
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Hong Kong, Hong Kong
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Kuala Lumpur, 56000, Malaysia
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Mexico City, 06726, Mexico
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Mexico City, 14000, Mexico
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Mexico City, 14080, Mexico
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Mérida, 97070, Mexico
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Panama City, 83-0669, Panama
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Callao, Peru
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Lima, 13, Peru
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Kazan', 420029, Russia
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Moscow, 115478, Russia
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Saint Petersburg, 197758, Russia
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Ufa, 450054, Russia
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Seoul, 135-170, South Korea
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Seoul, 135-720, South Korea
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Seoul, 138-736, South Korea
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Seoul, 405-760, South Korea
Unknown Facility
Montevideo, 11600, Uruguay
Related Publications (1)
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.
PMID: 29372626DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2015
First Posted
September 29, 2015
Study Start
April 1, 2003
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
November 2, 2016
Record last verified: 2016-11