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Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.
Conditions
DSF
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Fluorouracil Implants
Type: Drug
Name: Xelox regimes
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
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.
Location
Heilongjiang Cancer Hospital
Harebin, Heilongjiang, China
Status: Recruiting
Contact: Chunfeng Li, Doctor - 18745787187 - lichunfeng007@163.com
Start Date
April 2014
Completion Date
June 2018
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Source
Jiangsu Simcere Pharmaceutical Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page