NCT03941561RecruitingPhase 3
S-1 for 9 Months Versus 1 Year for Stage II Gastric Cancer (SMAC)
Compare S-1 for 9 Months to 1 Year as Adjuvant Chemotherapy in Stage II Gastric Cancer (SMAC)
Source: ClinicalTrials.gov · Last updated 31 May 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1006 (estimated)
- First submitted
- 6 May 2019
- Start date
- 1 Jan 2019
- Primary completion date
- 1 Jan 2022
- Lead sponsor
- Fudan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03941561
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1006
- From 1 Jan 2019 to the primary completion date, 1 Jan 2022
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy.
- Unavailable for R0 resection and D2 lymph node dissection.
- Patients (within 4 weeks) are receiving any other anti-cancer drugs therapy, biological therapy, radiation therapy, or Immunosuppressive therapy.
Other illness
- 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.
- Patients conform to any of the following: post-organ transplant, necessary for long-term immunosuppressive or suffering with autoimmune diseases.
Other
- Patients with stage I, III and IV.
- The researchers believe the patient is not able to complete the entire course of the experiment.
Who the study is looking for
- 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).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anqing Municipal Hospital Coordinator of this site? Confirm its status | Anqing | China | Recruiting |
| Second Affiliated Hospital, School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Jiangxi Provincial Cancer Hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Dazhi Xu Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| First Affiliated Hospital of Wannan Medical College Coordinator of this site? Confirm its status | Wuhu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.