Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer
CAPITAL
A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer
2 other identifiers
interventional
724
1 country
13
Brief Summary
Background: It is shown that TS-1 as adjuvant chemotherapy after D2 resection in patients with gastric cancer can improve DFS and OS in one Japanese Trial. And TS-1 has become one of the standard therapies to these patients. But it is still unknown whether it would improve more to OS and DFS than single TS-1 after combined with oxaliplatin . This trial is designed to investigate the efficacy and safety of TS-1 plus oxaliplatin versus TS-1 single as adjuvant chemotherapy after D2 resection in patients with gastric cancer. 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.
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 Sep 2011
Typical duration for phase_3 gastric-cancer
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 14, 2013
CompletedFirst Posted
Study publicly available on registry
February 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedOctober 25, 2016
October 1, 2016
5.2 years
February 14, 2013
October 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
5 year
Secondary Outcomes (2)
disease-free survival
3 year
Number of Participants with Adverse Events
5 year
Study Arms (2)
S-1 plus Oxaliplatin
EXPERIMENTAL6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
S-1 single
ACTIVE COMPARATORS-1 40\~60mg twice daily for 14 days in 3 weeks for totally 16 courses after D2 resection
Interventions
6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
Eligibility Criteria
You may qualify if:
- informed consensus of patients
- 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
You may not qualify if:
- history of other malignancy
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhiwei Zhou, PHD
SunYat-sen University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Gastric and Pancreatic Surgery,cancer center of Sun Yat-sen U
Study Record Dates
First Submitted
February 14, 2013
First Posted
February 20, 2013
Study Start
September 1, 2011
Primary Completion
November 1, 2016
Study Completion
June 1, 2018
Last Updated
October 25, 2016
Record last verified: 2016-10