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

Official title

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

Overview

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

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.

Interventions

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

Primary outcome measures

• DFS [Time frame: 3-year]

Secondary outcome measures (1)

• OS [Time frame: 5-year]

Eligibility criteria

Inclusion criteria

• The lower age limit of research subjects 18 years old and upper age limit of 75 years old.
• Be proven to be primary adenocarcinoma of gastric cancer and staged II by pathological evidence
• R0 surgery with lymphadenectomy
• Without any other malignancies
• ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
• 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 6 centers

• Anqing Municipal Hospital — Anqing
• Second Affiliated Hospital, School of Medicine — Hangzhou
• Anhui Provincial Hospital — Hefei
• Jiangxi Provincial Cancer Hospital — Nanchang
• Dazhi Xu — Shanghai
• First Affiliated Hospital of Wannan Medical College — Wuhu

Identifiers

NCT: NCT03941561 · CGCG006

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗