S-1 for 9 Months Versus 1 Year for Stage II Gastric Cancer (SMAC）

Compare S-1 for 9 Months to 1 Year as Adjuvant Chemotherapy in Stage II Gastric Cancer (SMAC）

The study aims to compare the efficacy and safety of S-1 for 9 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 9 months shows non-inferiority to S-1 for 1 year in disease-free survival(DFS), overall survival (OS) and safety.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: S-1 for 9 months; Drug: S-1 for 1 year

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 9 months. As a result, An further clinical trial is still needed, This trial is designed to investigate the efficacy and safety of S-1 for 9 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 and who received D2 resection were randomly assigned to receive S-1 for 9 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 9 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 endpoint is 3-year DFS, and the secondary endpoint is 5-year OS and safety. Final study analysis will be conducted at the end of the 5th year after the last patient's enrollment. In summary, we hold the hypothesis that S-1 for 9 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
• Enrollment (Anticipated): 1006
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anqing, China
    • Recruiting
    • Anqing Municipal Hospital
  • Hangzhou, China
    • Recruiting
    • Second Affiliated Hospital, School of Medicine
  • Hefei, China
    • Recruiting
    • Anhui Provincial Hospital
  • Nanchang, China
    • Recruiting
    • Jiangxi Provincial Cancer Hospital
  • Shanghai, China
    • Recruiting
    • Dazhi Xu
    • Contact: Dazhi Xu, PHD,MD; Email: xudzh@sysucc.org.cn
  • Wuhu, China
    • Recruiting
    • First Affiliated Hospital of Wannan Medical College

Participation Criteria

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. The 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 by pathological evidence
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, III 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; S-1 for 1 year after D2 resection; Other Names: Tegafur,Gimeracil and Oteracil Porassium Capsules
Experimental: S-1 for 9 months; S-1 80-120mg daily for 14 days in 3 weeks for totally 9 months after D2 resection	Drug: S-1 for 9 months; S-1 for 9 months after D2 resection; Other Names: Tegafur,Gimeracil and Oteracil Porassium Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS	Disease-free survival	3-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall survival	5-year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Complications such as Nausea, vomiting, myelosuppression, and Liver or kidney function disorder	1-year

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): May 1, 2027

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Gastric Cancer; S-1
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tegafur
• Other Study ID Numbers: CGCG006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No