DSF
Conditions
Brief summary
SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is a post-marketing study. The subjects will be divided into two groups (Group A and Group B ). The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan during operation and 6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will receive D2 radical gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The subject's benefits from SinoFuan will be analyzed through comparing 3 years DFS of two groups.
Interventions
Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation.
DRUGXelox regimes
Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. primary gastric cancer, Phase III 2. D2 radical gastrectomy(R0) 3. 18 year old or above 4. KPS≥70%； 5. suitable hematologic function: ANC≥1.5×109/L, PLC≥80×109/L 6. suitable liver function: Total bilirubin≤1.5×normal ULN, AST and ALT≤2.5×normal ULN. 7. suitable renal function: Cr≤1.5×normal ULN,or Ccr≥50 ml/min 8 .for the female subject, pregnancy test must be negative in 27 hours before enrollment . 9\. the authorized ICF must be signed
Exclusion criteria
1. non-initial gastric cancer； 2. having the other uncontrolled diseases. 3. obvious loss of weight ( more than 10% within 6 weeks ) 4. the female in pregnancy or feeding. 5. contraindication to study drug 6. participating in other clinical trial and at the time of treatment period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DFS (Disease Free Survival) | 3 year | During 3 years of monitoring period, any cancer relapse will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse event | 3 years | During 3 years of monitoring period, any AEs will be recorded |
Countries
China
Contacts
Primary ContactYan Xu, Doctor
Backup ContactBo Li, Doctor
Outcome results
None listed