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

NCT ID: NCT03941561

Last Updated: 2019-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1006 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2027-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastric Cancer

Keywords

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Gastric Cancer S-1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S-1 for 9 months

S-1 80-120mg daily for 14 days in 3 weeks for totally 9 months after D2 resection

Group Type EXPERIMENTAL

S-1 for 9 months

Intervention Type DRUG

S-1 for 9 months after D2 resection

S-1 for 1 year

S-1 80-120mg daily for 14 days in 3 weeks for totally 1 year after D2 resection

Group Type ACTIVE_COMPARATOR

S-1 for 1 year

Intervention Type DRUG

S-1 for 1 year after D2 resection

Interventions

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S-1 for 9 months

S-1 for 9 months after D2 resection

Intervention Type DRUG

S-1 for 1 year

S-1 for 1 year after D2 resection

Intervention Type DRUG

Other Intervention Names

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Tegafur,Gimeracil and Oteracil Porassium Capsules Tegafur,Gimeracil and Oteracil Porassium Capsules

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Dazhi Xu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dazhi Xu, PHD, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Anqing Municipal Hospital

Anqing, , China

Site Status RECRUITING

Second Affiliated Hospital, School of Medicine

Hangzhou, , China

Site Status RECRUITING

Anhui Provincial Hospital

Hefei, , China

Site Status RECRUITING

Jiangxi Provincial Cancer Hospital

Nanchang, , China

Site Status RECRUITING

Dazhi Xu

Shanghai, , China

Site Status RECRUITING

First Affiliated Hospital of Wannan Medical College

Wuhu, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dazhi Xu, PHD, MD

Role: CONTACT

Phone: (+86) 020-87343737

Email: [email protected]

Facility Contacts

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Yaming Zhang, MD

Role: primary

Li Chen, MD

Role: primary

Xuhui Zhao, MD

Role: primary

Huamin Rao, MD

Role: primary

Dazhi Xu, PHD,MD

Role: primary

Lianghui Shi, MD

Role: primary

Other Identifiers

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CGCG006

Identifier Type: -

Identifier Source: org_study_id