Clinical trial NCT01795027: Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: gastric cancer
chemotherapy
D2 resection
S-1
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 724
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: overall survival
timeFrame: 5 year
Secondary outcomes:
measure: disease-free survival
timeFrame: 3 year
measure: Number of Participants with Adverse Events
timeFrame: 5 year
Other outcomes:
Locations:
city: Chaozhou
country: China
facility: the central hospital of Chaozhou
state: Guangdong
city: Foshan
country: China
facility: the 1st people's hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: cancer center of Guangzhou medical college
state: Guangdong
city: Guangzhou
country: China
facility: cancer center of Sun yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Traditional Medical Hospital
state: Guangdong
city: Guangzhou
country: China
facility: the 1st affliated hospital of Guangdong pharmacuetic college
state: Guangdong
city: Guangzhou
country: China
facility: the 1St Affliated Hospital of Guangzhou Medical College
state: Guangdong
city: Guangzhou
country: China
facility: the 6th affliated hospital of Sun-yat-sen University
state: Guangdong
city: Shantou
country: China
facility: the 1st hospital of Shantou University
state: Guangdong
city: Shantou
country: China
facility: the cental hospital of Shantou
state: Guangdong
city: Shaoguan
country: China
facility: YUE-BEI people's hospital
state: Guangdong
city: Shenzhen
country: China
facility: the 2nd people's hospital of Shenzhen
state: Guangdong
city: Zhuhai
country: China
facility: the 5th hospital of Sun-yat-sen University
state: Guangdong
Study officials:
affiliation: SunYat-sen University
name: Zhiwei Zhou, PHD
role: STUDY_CHAIR
References: