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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
S-1 plus oxaliplatin
S-1 single
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, chemotherapy, D2 resection, S-1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the central hospital of Chaozhou
  • the 1st people's hospital of Foshan
  • cancer center of Guangzhou medical college
  • cancer center of Sun yat-sen University
  • Guangdong Traditional Medical Hospital
  • the 1st affliated hospital of Guangdong pharmacuetic college
  • the 1St Affliated Hospital of Guangzhou Medical College
  • the 6th affliated hospital of Sun-yat-sen University
  • the 1st hospital of Shantou University
  • the cental hospital of Shantou
  • YUE-BEI people's hospital
  • the 2nd people's hospital of Shenzhen
  • the 5th hospital of Sun-yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

S-1 plus Oxaliplatin

S-1 single

Arm Description

6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection

S-1 40~60mg twice daily for 14 days in 3 weeks for totally 16 courses after D2 resection

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

disease-free survival
Number of Participants with Adverse Events

Full Information

First Posted
February 14, 2013
Last Updated
October 23, 2016
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01795027
Brief Title
Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, chemotherapy, D2 resection, S-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
724 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S-1 plus Oxaliplatin
Arm Type
Experimental
Arm Description
6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
Arm Title
S-1 single
Arm Type
Active Comparator
Arm Description
S-1 40~60mg twice daily for 14 days in 3 weeks for totally 16 courses after D2 resection
Intervention Type
Drug
Intervention Name(s)
S-1 plus oxaliplatin
Other Intervention Name(s)
SOX
Intervention Description
6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
Intervention Type
Drug
Intervention Name(s)
S-1 single
Other Intervention Name(s)
S-1
Intervention Description
16 courses S-1 single after d D2 resection
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5 year
Secondary Outcome Measure Information:
Title
disease-free survival
Time Frame
3 year
Title
Number of Participants with Adverse Events
Time Frame
5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiwei Zhou, PHD
Organizational Affiliation
SunYat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
the central hospital of Chaozhou
City
Chaozhou
State/Province
Guangdong
Country
China
Facility Name
the 1st people's hospital of Foshan
City
Foshan
State/Province
Guangdong
Country
China
Facility Name
cancer center of Guangzhou medical college
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
cancer center of Sun yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Guangdong Traditional Medical Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
the 1st affliated hospital of Guangdong pharmacuetic college
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
the 1St Affliated Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
the 6th affliated hospital of Sun-yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
the 1st hospital of Shantou University
City
Shantou
State/Province
Guangdong
Country
China
Facility Name
the cental hospital of Shantou
City
Shantou
State/Province
Guangdong
Country
China
Facility Name
YUE-BEI people's hospital
City
Shaoguan
State/Province
Guangdong
Country
China
Facility Name
the 2nd people's hospital of Shenzhen
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
the 5th hospital of Sun-yat-sen University
City
Zhuhai
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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