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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2016 |
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Main ID: |
NCT02563054 |
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Date of registration:
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28/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer
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Scientific title:
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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 |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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316 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02563054 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Belize
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Brazil
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China
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Colombia
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Guatemala
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Hong Kong
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Korea, Republic of
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Malaysia
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Mexico
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Panama
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Peru
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Russian Federation
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Uruguay
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults 18 to 75 years of age
- Advanced and/or metastatic gastric cancer with at least 1 measurable lesion
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastric Cancer
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Intervention(s)
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Drug: Cisplatin
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Drug: Capecitabine
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Drug: 5-Fluorouracil
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Primary Outcome(s)
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Time to disease progression
[Time Frame: Up to approximately 7.3 years]
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Secondary Outcome(s)
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Overall survival
[Time Frame: Up to approximately 7.3 years]
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Incidence of adverse events
[Time Frame: Up to approximately 7.3 years]
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Time to response
[Time Frame: Up to approximately 7.3 years]
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Duration of response
[Time Frame: Up to approximately 7.3 years]
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Objective tumor response rate
[Time Frame: Up to approximately 7.3 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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