Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.

Study Overview
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Brief Summary
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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.

Official Title
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Fluorouracil Implants（SinoFuan®）Used for Intraperitoneal Chemotherapy During Operation for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer, Randomized, Controlled, Multicentres Open Study.

Conditions
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DSF

Intervention / Treatment
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* Drug: Fluorouracil Implants
* Drug: Xelox regimes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary gastric cancer, Phase III D2 radical gastrectomy(R0) 18 year old or above KPS≥70%； suitable hematologic function: ANC≥1.5×109/L, PLC≥80×109/L suitable liver function: Total bilirubin≤1.5×normal ULN, AST and ALT≤2.5×normal ULN. 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: non-initial gastric cancer； having the other uncontrolled diseases. obvious loss of weight ( more than 10% within 6 weeks ) the female in pregnancy or feeding. contraindication to study drug participating in other clinical trial and at the time of treatment period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluorouracil Implants and Xelox regimes<br>Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation. 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. | Drug: Fluorouracil Implants<br>* Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation.<br>Drug: Xelox regimes<br>* 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.<br>|
| Active Comparator: Xelox regimes<br>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. | Drug: Xelox regimes<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS (Disease Free Survival) | During 3 years of monitoring period, any cancer relapse will be recorded | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event | During 3 years of monitoring period, any AEs will be recorded | 3 years |