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

October 23, 2016 updated by: Zhou Zhiwei, Sun Yat-sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

724

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Chaozhou, Guangdong, China
        • the central hospital of Chaozhou
      • Foshan, Guangdong, China
        • The 1st People's Hospital of Foshan
      • Guangzhou, Guangdong, China
        • Cancer center of Sun Yat-sen University
      • Guangzhou, Guangdong, China
        • cancer center of Guangzhou medical college
      • 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
      • Shantou, Guangdong, China
        • the 1st hospital of Shantou University
      • Shantou, Guangdong, China
        • the cental hospital of Shantou
      • Shaoguan, Guangdong, China
        • YUE-BEI people's hospital
      • Shenzhen, Guangdong, China
        • The 2nd People's Hospital of Shenzhen
      • Zhuhai, Guangdong, China
        • the 5th hospital of Sun-yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-1 plus Oxaliplatin
6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
Drug: S-1 plus oxaliplatin
6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
Other Names:
  • SOX
Active Comparator: S-1 single
S-1 40~60mg twice daily for 14 days in 3 weeks for totally 16 courses after D2 resection
Drug: S-1 single
16 courses S-1 single after d D2 resection
Other Names:
  • S-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 5 year
5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
disease-free survival
Time Frame: 3 year
3 year
Number of Participants with Adverse Events
Time Frame: 5 year
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Zhiwei Zhou, PHD, SunYat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

February 14, 2013

First Submitted That Met QC Criteria

February 16, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 23, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCCGPS
  • ZHOUZHIWEI (Registry Identifier: ZZHIWEI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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