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 | Intervention/treatment | Phase |
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Gastric Cancer | Drug: S-1 for 9 months Drug: S-1 for 1 year | Phase 3 |
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 (Clinical Trial) |
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 1, 2019 |
Estimated Primary Completion Date : | January 1, 2022 |
Estimated Study Completion Date : | May 1, 2027 |
Arm | Intervention/treatment |
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Experimental: S-1 for 9 months
S-1 80-120mg daily for 14 days in 3 weeks for totally 9 months after D2 resection
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Drug: S-1 for 9 months
S-1 for 9 months after D2 resection
Other Name: Tegafur,Gimeracil and Oteracil Porassium Capsules
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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
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Drug: S-1 for 1 year
S-1 for 1 year after D2 resection
Other Name: Tegafur,Gimeracil and Oteracil Porassium Capsules
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dazhi Xu, PHD, MD | (+86) 020-87343737 | xudzh@sysucc.org.cn |
China | |
Anqing Municipal Hospital | Recruiting |
Anqing, China | |
Contact: Yaming Zhang, MD | |
Second Affiliated Hospital, School of Medicine | Recruiting |
Hangzhou, China | |
Contact: Li Chen, MD | |
Anhui Provincial Hospital | Recruiting |
Hefei, China | |
Contact: Xuhui Zhao, MD | |
Jiangxi Provincial Cancer Hospital | Recruiting |
Nanchang, China | |
Contact: Huamin Rao, MD | |
Dazhi Xu | Recruiting |
Shanghai, China | |
Contact: Dazhi Xu, PHD,MD xudzh@sysucc.org.cn | |
First Affiliated Hospital of Wannan Medical College | Recruiting |
Wuhu, China | |
Contact: Lianghui Shi, MD |
Principal Investigator: | Dazhi Xu, PHD, MD | Fudan University |
Tracking Information | |||||
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First Submitted Date ICMJE | May 6, 2019 | ||||
First Posted Date ICMJE | May 8, 2019 | ||||
Last Update Posted Date | May 31, 2019 | ||||
Actual Study Start Date ICMJE | January 1, 2019 | ||||
Estimated Primary Completion Date | January 1, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
DFS [ Time Frame: 3-year ] Disease-free survival
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
OS [ Time Frame: 5-year ] Overall survival
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
Side effects [ Time Frame: 1-year ] Complications such as Nausea, vomiting, myelosuppression, and Liver or kidney function disorder
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | S-1 for 9 Months Versus 1 Year for Stage II Gastric Cancer (SMAC) | ||||
Official Title ICMJE | Compare S-1 for 9 Months to 1 Year as Adjuvant Chemotherapy in Stage II Gastric Cancer (SMAC) | ||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Gastric Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
1006 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | May 1, 2027 | ||||
Estimated Primary Completion Date | January 1, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03941561 | ||||
Other Study ID Numbers ICMJE | CGCG006 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Dazhi Xu, Fudan University | ||||
Study Sponsor ICMJE | Fudan University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Fudan University | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |