Gastric CancerPhase 3NCT03941561
S-1 for 9 Months Versus 1 Year for Stage II Gastric Cancer (SMAC）
A Phase 3 study testing S-1 for 9 months and S-1 for 1 year in people with Gastric Cancer, run by Fudan University at 6 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- S-1 for 9 months and S-1 for 1 year
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,006 participants
- Where
- 6 sitesChina
- Study dates
- 1 Jan 2019to 1 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Anqing Municipal Hospital
Anqing
Yaming Zhang, MD
- Recruiting
Second Affiliated Hospital, School of Medicine
Hangzhou
Li Chen, MD
- Recruiting
Anhui Provincial Hospital
Hefei
Xuhui Zhao, MD
- Recruiting
Jiangxi Provincial Cancer Hospital
Nanchang
Huamin Rao, MD
- Recruiting
Dazhi Xu
Shanghai
Dazhi Xu, PHD,MD, xudzh@sysucc.org.cn
- Recruiting
First Affiliated Hospital of Wannan Medical College
Wuhu
Lianghui Shi, MD
About this study
Official title: Compare S-1 for 9 Months to 1 Year as Adjuvant Chemotherapy in Stage II Gastric Cancer (SMAC）
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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- S-1 for 9 months, S-1 for 1 year
- Keywords
- Gastric Cancer, S-1
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1 for 9 monthsDrug
Also called Tegafur,Gimeracil and Oteracil Porassium Capsules
S-1 for 9 months after D2 resection
S-1 for 1 yearDrug
Also called Tegafur,Gimeracil and Oteracil Porassium Capsules
S-1 for 1 year after D2 resection
| Study group | Role | What they receive |
|---|---|---|
| S-1 for 9 months | Experimental | S-1 80-120mg daily for 14 days in 3 weeks for totally 9 months after D2 resection Receives: Drug: S-1 for 9 months |
| S-1 for 1 year | Active comparator | S-1 80-120mg daily for 14 days in 3 weeks for totally 1 year after D2 resection Receives: Drug: S-1 for 1 year |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
Disease-free survival
Measured: 3-year
Secondary outcomes (1)
OS
Overall survival
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,006 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dazhi Xu, Fudan University
- Investigators
- Dazhi Xu, PHD, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941561
- Sponsor's protocol ID
- CGCG006
- Status last verified
- May 2019
- First submitted
- 6 May 2019
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare S-1 for 9 Months to 1 Year as Adjuvant Chemotherapy in Stage II Gastric Cancer (SMAC）
- ClinicalTrials.gov ID
- NCT03941561
- Acronym / sponsor ID
- CGCG006
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, S-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,006 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-1 for 9 months | Experimental | Drug: S-1 for 9 monthsS-1 80-120mg daily for 14 days in 3 weeks for totally 9 months after D2 resection |
| S-1 for 1 year | Active comparator | Drug: S-1 for 1 yearS-1 80-120mg daily for 14 days in 3 weeks for totally 1 year after D2 resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1 for 9 monthsAlso: Tegafur,Gimeracil and Oteracil Porassium CapsulesS-1 for 9 months after D2 resection | Drug | S-1 for 9 months |
| S-1 for 1 yearAlso: Tegafur,Gimeracil and Oteracil Porassium CapsulesS-1 for 1 year after D2 resection | Drug | S-1 for 1 year |
Primary outcome
DFS
Time frame: 3-year
Disease-free survival
1 secondary outcome
OS
Time frame: 5-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dazhi Xu, PHD, MD principal investigator
Fudan University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S-1 for 9 months and S-1 for 1 year in people with Gastric Cancer, run by Fudan University at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dazhi Xu, PHD, MD ((+86) 020-87343737, xudzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.