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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03941561
• Other study ID #: CGCG006
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2019
• Est. completion date: May 1, 2027

Study information

• Verified date: May 2019
• Source: Fudan University
• Contact: Dazhi Xu, PHD, MD
• Phone: (+86) 020-87343737
• Email: xudzh[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1006
• Est. completion date: May 1, 2027
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1 for 9 months
S-1 for 9 months after D2 resection
• S-1 for 1 year
S-1 for 1 year after D2 resection

Locations

Country	Name	City	State
China	Anqing Municipal Hospital	Anqing
China	Second Affiliated Hospital, School of Medicine	Hangzhou
China	Anhui Provincial Hospital	Hefei
China	Jiangxi Provincial Cancer Hospital	Nanchang
China	Dazhi Xu	Shanghai
China	First Affiliated Hospital of Wannan Medical College	Wuhu

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects	Complications such as Nausea, vomiting, myelosuppression, and Liver or kidney function disorder	1-year
Primary	DFS	Disease-free survival	3-year
Secondary	OS	Overall survival	5-year