Back to resultsA Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Capecitabine
Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Capecitabine + Oxaliplatin
Observation
Arm Description
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).
Participants will not receive any treatment but will be seen regularly by a physician.
Outcomes
Primary Outcome Measures
Disease-free survival rate
Secondary Outcome Measures
Overall survival
Incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02560974
Brief Title
A Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
1035 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine + Oxaliplatin
Arm Type
Experimental
Arm Description
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).
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Participants will not receive any treatment but will be seen regularly by a physician.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine will be administered orally at 1000 mg/m^2 BID on Days 1 to 15 of a 3-week cycle, for 8 cycles.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin will be administered as an IV infusion, 130 mg/m^2 on Day 1 of each 3-week cycle for 8 cycles.
Primary Outcome Measure Information:
Title
Disease-free survival rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years
Title
Incidence of adverse events
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Beijing
ZIP/Postal Code
100044
Country
China
City
Beijing
ZIP/Postal Code
100142
Country
China
City
Fujian
ZIP/Postal Code
350001
Country
China
City
Guangzhou
ZIP/Postal Code
510060
Country
China
City
Guangzhou
ZIP/Postal Code
510080
Country
China
City
Shanghai
ZIP/Postal Code
200025
Country
China
City
Shanghai
ZIP/Postal Code
200032
Country
China
City
Shenyang
ZIP/Postal Code
110001
Country
China
City
Tianjin
ZIP/Postal Code
300060
Country
China
City
Bundang City
ZIP/Postal Code
463-802
Country
Korea, Republic of
City
Busan
ZIP/Postal Code
49267
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
702-210
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
City
Gyeonggi-do
ZIP/Postal Code
443-380
Country
Korea, Republic of
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
City
Jeollabuk-do
ZIP/Postal Code
561-712
Country
Korea, Republic of
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
134-791
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
139-709
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
140-743
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Suwon
Country
Korea, Republic of
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
City
Taipei
Country
Taiwan
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer
We'll reach out to this number within 24 hrs