A Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer
NCT ID: NCT02560974
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
1035 participants
INTERVENTIONAL
2006-06-30
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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Capecitabine + Oxaliplatin
Patients will receive oral capecitabine (1000 mg/m\^2 BID on Days 1 to 15 ) plus IV oxaliplatin (130 mg/m\^2 on Day 1) during each 3-week cycle for up to 8 cycles (6 months).
Capecitabine
Capecitabine will be administered orally at 1000 mg/m\^2 BID on Days 1 to 15 of a 3-week cycle, for 8 cycles.
Oxaliplatin
Oxaliplatin will be administered as an IV infusion, 130 mg/m\^2 on Day 1 of each 3-week cycle for 8 cycles.
Observation
Participants will not receive any treatment but will be seen regularly by a physician.
No interventions assigned to this group
Interventions
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Capecitabine
Capecitabine will be administered orally at 1000 mg/m\^2 BID on Days 1 to 15 of a 3-week cycle, for 8 cycles.
Oxaliplatin
Oxaliplatin will be administered as an IV infusion, 130 mg/m\^2 on Day 1 of each 3-week cycle for 8 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gastric adenocarcinoma, Stage II, IIIa or IIIb
* Potentially curative resection of tumor within 6 weeks prior to randomization
* Previously untreated with chemotherapy or radiotherapy
Exclusion Criteria
* Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
* Any evidence of metastatic disease (including presence of tumor cells in the ascites)
18 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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Beijing, , China
Beijing, , China
Fujian, , China
Guangzhou, , China
Guangzhou, , China
Shanghai, , China
Shanghai, , China
Shenyang, , China
Tianjin, , China
Bundang City, , South Korea
Busan, , South Korea
Daegu, , South Korea
Daegu, , South Korea
Daegu, , South Korea
Gyeonggi-do, , South Korea
Gyeonggi-do, , South Korea
Incheon, , South Korea
Jeollabuk-do, , South Korea
Jeollanam-do, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Suwon, , South Korea
Changhua, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Countries
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Other Identifiers
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MO17527
Identifier Type: -
Identifier Source: org_study_id