Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer

Gastric Cancer Clinical Trial

— CAPITAL  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01795027
• Other study ID #: SYSUCCGPS
• Secondary ID: ZHOUZHIWEI
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 14, 2013
• Last updated: October 23, 2016
• Start date: September 2011
• Est. completion date: June 2018

Study information

• Verified date: October 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 724
• Est. completion date: June 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		5 year	Yes
Secondary	disease-free survival		3 year	Yes
Secondary	Number of Participants with Adverse Events		5 year	Yes