Compare S-1 for 6 Months to 1 Year as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer Staged II , IIIA or IIIB.

May 6, 2019 updated by: Dazhi Xu, Fudan University

A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 for 6 Months to 1 Year as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer Staged II , IIIA or IIIB.

The study aims to compare the efficacy and safety of S-1 for 6 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer.

Hypothesis: For gastric patients after D2 resection, S-1 for 6 months shows non-inferiority to S-1 for 1 year in disease free survival(DFS), overall survival (OS) and safety.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

It has been identified that S-1 is an effective adjuvant treatment for East Asian patients who have undergone a D2 dissection for locally advanced gastric cancer（GC) in the Japanese Adjuvant Chemotherapy Trial of TS-1（S-1) for Gastric Cancer (ACTS-GC) trail , And S-1 has become one of the standard therapies to these patients. But it is still unknown whether it would improve equally or even more to overall survival(OS) and disease free survival(DFS) than S-1 for 1 year compared with S-1 for 6 months. As a result , An further clinical trail is still needed, This trial is designed to investigate the efficacy and safety of S-1 for 6 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer.

In this study, patients histologically confirmed stage II, IIIA or IIIB and who received D2 resection were randomly assigned to receive S-1 for 6 months or S-1 for 1 year. Patients aged from 18 to 75 years and adequate organ function, are randomized 1:1 to S-1 for 6 months and S-1 for 1 year. Both are the 3-week recycle of S-1 (80-120mg per day) for 2 weeks ,followed by 1 week of rest. The primary end point is 3-year DFS, and secondary end point is 5-year OS and safety. Final study analysis will be conducted in the end of the 5th year after the last patient's enrollment.In summary, we hold the hypothesis that S-1 for 6 months is equally effective, safer, and easier to carry out. If possible, there will be a new adjuvant chemotherapy strategy for gastric cancer patients after D2 resection.

To ensure the quality of the study, two interim analyses will be planned at the half and the completion of the study respectively. The DATA and Safety Monitoring Committee will independently review the interim analysis and stop the study ahead of schedule if necessary. Furthermore, to improve the study progress and quality, the in-house interim monitoring will be performed.

Study Type

Interventional

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
    • Anhui
      • Anqing, Anhui, China
        • Anqing Municipal Hospital
      • Hefei, Anhui, China
        • Anhui Provincial Hospital
      • Hefei, Anhui, China
        • The First Affiliated Hospital of Anhui Medical University
      • Wuhu, Anhui, China
        • First Affiliated Hospital of Wannan Medical College
    • Guangdong
      • Guangzhou, Guangdong, China
        • Cancer center of Sun Yat-sen University
      • Guangzhou, Guangdong, China
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
      • Guangzhou, Guangdong, China
        • Yuebei People's Hospital
      • Shenzhen, Guangdong, China
        • Shenzhen People's Hospital
    • Zhejiang
      • Lishui, Zhejiang, China
        • Lishui Hospital of Zhejiang 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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Lower age limit of research subjects 18 years old and upper age limit of 75 years old.
  2. Be proven to be primary adenocarcinoma of gastric cancer and staged II，IIIA or IIIB by pathological evidences
  3. R0 surgery with lymphadenectomy
  4. Without any other malignancies
  5. ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
  6. No contraindications to chemotherapy, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L,PLT≥100 x 109 /L and HGB≥90g/L).

Exclusion Criteria:

  1. Female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy.
  2. Patients with stage I, IIIC and IV.
  3. Unavailable for R0 resection and D2 lymph node dissection.
  4. Suffering from other uncontrolled diseases, such as other tumors, acute and Chronic infection.
  5. With severe heart disease, including: congestive heart failure, uncontrolled arrhythmias, unstable angina, myocardial infarction, severe heart valve disease and resistant hypertension.
  6. Any Known or suspected history of drug allergy test.
  7. The researchers believe the patient is not able to complete the entire course of the experiment.
  8. Patients (within 4 weeks) are receiving any other anti-cancer drugs therapy, biological therapy, radiation therapy, or Immunosuppressive therapy.
  9. Patients conform to any of the following: post-organ transplant, necessary for long-term immunosuppressive or suffering with autoimmune diseases.

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 for 6 months
S-1 80-120mg daily for 14 days in 3 weeks for totally 6 months after D2 resection
Drug: S-1 for 6 months
6 months S-1 after D2 resection
Active Comparator: S-1 for 1 year
S-1 80-120mg daily for 14 days in 3 weeks for totally 1 year after D2 resection
Drug: S-1 for 1 year
1 year S-1 after D2 resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: 3-year
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5-year
5-year
Overall survival
Time Frame: 3-year
3-year
Side effects
Time Frame: 12 months
Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment expense
Time Frame: 12 months
Total costs of treatment
12 months

Collaborators and Investigators

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

Sponsor

Fudan University

Collaborators

The First Affiliated Hospital of Anhui Medical University
Guangdong Provincial Hospital of Traditional Chinese Medicine
Sun Yat-sen University
Shenzhen People's Hospital
Anhui Provincial Hospital
Anqing Municipal Hospital
Yuebei People's Hospital
The First Affiliated Hospital of Guangdong Pharmaceutical University
First Affiliated Hospital of Wannan Medical College
Lishui hospital of Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

March 1, 2016

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 7, 2016

First Posted (Estimate)

April 13, 2016

Study Record Updates

Last Update Posted (Actual)

May 8, 2019

Last Update Submitted That Met QC Criteria

May 6, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGCG001

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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