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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

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

Clinicaltrials.gov identifier NCT03941561

Recruitment Status Recruiting

First Posted May 8, 2019

Last update posted May 31, 2019

Study Description

Brief 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.

  • Condition or Disease:Gastric Cancer
  • Intervention/Treatment: Drug: S-1 for 9 months
    Drug: S-1 for 1 year
  • Phase: Phase 3
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 1006 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Compare S-1 for 9 Months to 1 Year as Adjuvant Chemotherapy in Stage II Gastric Cancer (SMAC)
  • Actual Study Start Date: January 2019
  • Estimated Primary Completion Date: January 2022
  • Estimated Study Completion Date: May 2027
Arms and interventions
Arm Intervention/treatment
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
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
Outcome Measures
  • Primary Outcome Measures: 1. DFS [ Time Frame: 3-year ]
    Disease-free survival
  • Secondary Outcome Measures: 1. OS [ Time Frame: 5-year ]
    Overall survival
  • Other Outcome Measures: 1. Side effects [ Time Frame: 1-year ]
    Complications such as Nausea, vomiting, myelosuppression, and Liver or kidney function disorder
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts

Contact: Dazhi Xu, PHD, MD (+86) 020-87343737 xudzh@sysucc.org.cn

Locations

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 and Collaborators

Fudan University

Investigators

Principal Investigator: Dazhi Xu, PHD, MD Fudan University

More Information
  • Responsible Party: Fudan University
  • ClinicalTrials.gov Identifier: NCT03941561 History of Changes
  • Other Study ID Numbers: CGCG006
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: May 31, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Fudan University: Gastric Cancer S-1
  • Additional relevant MeSH terms: Stomach Neoplasms