Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer
NCT ID: NCT01795027
Last Updated: 2016-10-25
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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UNKNOWN
PHASE3
724 participants
INTERVENTIONAL
2011-09-30
2018-06-30
Brief Summary
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Patients and methods: In this study , patients with histologically confirmed gastric cancer who received D2 resection and staged II or III, aged from 18 to 70 years and with Eastern Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized 1:1 to oxaliplatin 100mg/m2 on day 1 and TS-1 40\~60mg twice everyday for 14 days in a 21-days cycle for total 6 cycles followed by TS-1 single with the same dose and frequency to the end of the 1st year postoperatively(SOX) , or TS-1 single 40\~60mg twice everyday for 14 days in a 21-days cycle to the end of the 1st year postoperatively (TS-1). The primary end point is overall survival (OS), and secondary end point is disease free survival(DFS) and safety. Final study analysis will be conducted in the end of the 5th year after the last patient's enrollment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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S-1 plus Oxaliplatin
6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
S-1 plus oxaliplatin
6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
S-1 single
S-1 40\~60mg twice daily for 14 days in 3 weeks for totally 16 courses after D2 resection
S-1 single
16 courses S-1 single after d D2 resection
Interventions
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S-1 plus oxaliplatin
6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
S-1 single
16 courses S-1 single after d D2 resection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* be able to receive oral administration
* from 18 to 70 years old
* be proven to be primary adenocarcinoma of gastric cancer and staged II or III by pathological evidences
* without other chemotherapy and/or radiation against to the disease
* normal function of other organs including heart,liver ,kidney and so on
* Eastern Cooperative Oncology Group performance status:0\~2
Exclusion Criteria
* allergic reaction to S-1 or oxaliplatin
* be enrolling in other clinical trials
* abnormal GI tract function
* dysfunction of other organs
* female in pregnancy or lactation,or refuse to receive Contraception measures during chemotherapy
* other situation to be judged not adaptive to the study by investigators
18 Years
70 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Zhou Zhiwei
Director of Gastric and Pancreatic Surgery,cancer center of Sun Yat-sen U
Principal Investigators
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Zhiwei Zhou, PHD
Role: STUDY_CHAIR
SunYat-sen University
Locations
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the central hospital of Chaozhou
Chaozhou, Guangdong, China
the 1st people's hospital of Foshan
Foshan, Guangdong, China
cancer center of Guangzhou medical college
Guangzhou, Guangdong, China
cancer center of Sun yat-sen University
Guangzhou, Guangdong, China
Guangdong Traditional Medical Hospital
Guangzhou, Guangdong, China
the 1st affliated hospital of Guangdong pharmacuetic college
Guangzhou, Guangdong, China
the 1St Affliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
the 6th affliated hospital of Sun-yat-sen University
Guangzhou, Guangdong, China
the 1st hospital of Shantou University
Shantou, Guangdong, China
the cental hospital of Shantou
Shantou, Guangdong, China
YUE-BEI people's hospital
Shaoguan, Guangdong, China
the 2nd people's hospital of Shenzhen
Shenzhen, Guangdong, China
the 5th hospital of Sun-yat-sen University
Zhuhai, Guangdong, China
Countries
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Other Identifiers
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ZHOUZHIWEI
Identifier Type: REGISTRY
Identifier Source: secondary_id
SYSUCCGPS
Identifier Type: -
Identifier Source: org_study_id
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