A Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer
A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin Versus Surgery Alone in Patients With Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4N0) and IIIb (T3N2) Gastric Adenocarcinoma
1 other identifier
interventional
1,035
3 countries
36
Brief Summary
This study will compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation alone in chemotherapy-naive participants who have undergone potentially curative resection for gastric cancer. Participants will be randomized to either the chemotherapy arm or the observation arm. Capecitabine will be administered orally, 1000 milligrams per meter-squared (mg/m\^2) twice daily (BID) on Days 1 to 15 of a 3-week cycle, for 8 cycles, and oxaliplatin will be administered as an intravenous (IV) infusion, 130 mg/m\^2 every 3 weeks for 8 cycles. The anticipated time on study treatment in 6 months and the target sample size is 1024 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 gastric-cancer
Started Jun 2006
Typical duration for phase_3 gastric-cancer
36 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
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 24, 2015
CompletedFirst Posted
Study publicly available on registry
September 25, 2015
CompletedNovember 2, 2016
November 1, 2016
6.4 years
September 24, 2015
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free survival rate
3 years
Secondary Outcomes (2)
Overall survival
5 years
Incidence of adverse events
5 years
Study Arms (2)
Capecitabine + Oxaliplatin
EXPERIMENTALPatients 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).
Observation
NO INTERVENTIONParticipants will not receive any treatment but will be seen regularly by a physician.
Interventions
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 will be administered as an IV infusion, 130 mg/m\^2 on Day 1 of each 3-week cycle for 8 cycles.
Eligibility Criteria
You may qualify if:
- Adult participants greater than or equal to (\>=) 18 years of age
- Gastric adenocarcinoma, Stage II, IIIa or IIIb
- Potentially curative resection of tumor within 6 weeks prior to randomization
- Previously untreated with chemotherapy or radiotherapy
You may not qualify if:
- Serious concomitant medical illnesses that would limit life expectancy to less than (\<) 5 years
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Unknown Facility
Beijing, 100044, China
Unknown Facility
Beijing, 100142, China
Unknown Facility
Fujian, 350001, China
Unknown Facility
Guangzhou, 510060, China
Unknown Facility
Guangzhou, 510080, China
Unknown Facility
Shanghai, 200025, China
Unknown Facility
Shanghai, 200032, China
Unknown Facility
Shenyang, 110001, China
Unknown Facility
Tianjin, 300060, China
Unknown Facility
Bundang City, 463-802, South Korea
Unknown Facility
Busan, 49267, South Korea
Unknown Facility
Daegu, 700-712, South Korea
Unknown Facility
Daegu, 702-210, South Korea
Unknown Facility
Daegu, South Korea
Unknown Facility
Gyeonggi-do, 10408, South Korea
Unknown Facility
Gyeonggi-do, 443-380, South Korea
Unknown Facility
Incheon, 405-760, South Korea
Unknown Facility
Jeollabuk-do, 561-712, South Korea
Unknown Facility
Jeollanam-do, 58128, South Korea
Unknown Facility
Seoul, 03080, South Korea
Unknown Facility
Seoul, 120-752, South Korea
Unknown Facility
Seoul, 130-872, South Korea
Unknown Facility
Seoul, 134-791, South Korea
Unknown Facility
Seoul, 135-720, South Korea
Unknown Facility
Seoul, 139-709, South Korea
Unknown Facility
Seoul, 140-743, South Korea
Unknown Facility
Seoul, 152-703, South Korea
Unknown Facility
Seoul, 158-710, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Suwon, South Korea
Unknown Facility
Changhua, 500, Taiwan
Unknown Facility
Tainan, 704, Taiwan
Unknown Facility
Taipei, 00112, Taiwan
Unknown Facility
Taipei, 104, Taiwan
Unknown Facility
Taipei, Taiwan
Unknown Facility
Taoyuan District, 333, Taiwan
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
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2015
First Posted
September 25, 2015
Study Start
June 1, 2006
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11