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

Phase 2

• Conditions: DSF
• Interventions: Drug: Fluorouracil Implants; Drug: Xelox regimes

• Registration Number: NCT02269904
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Status Verified: 2014-10
• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-17
• Last Update Submitted: 2014-10-17
• Study First Posted: 2014-10-21
• Last Update Posted: 2014-10-21
• Primary Completion: 2018-04
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 .

8. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluorouracil Implants and Xelox regimes	Xelox regimes	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.
Xelox regimes	Xelox 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.
Fluorouracil Implants and Xelox regimes	Fluorouracil Implants	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.

Primary Outcome Measures

Name	Time	Method
DFS (Disease Free Survival)	3 year	During 3 years of monitoring period, any cancer relapse will be recorded

Secondary Outcome Measures

Name	Time	Method
adverse event	3 years	During 3 years of monitoring period, any AEs will be recorded

Trial Locations

Locations (1)

Heilongjiang Cancer Hospital; 🇨🇳 Harebin, Heilongjiang, China