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Trial Title:
Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.
NCT ID:
NCT02269904
Condition:
DSF
Conditions: Official terms:
Stomach Neoplasms
Fluorouracil
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fluorouracil Implants
Description:
Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation.
Arm group label:
Fluorouracil Implants and Xelox regimes
Intervention type:
Drug
Intervention name:
Xelox regimes
Description:
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.
Arm group label:
Fluorouracil Implants and Xelox regimes
Arm group label:
Xelox regimes
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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Heilongjiang Cancer Hospital
Address:
City:
Harebin
Zip:
150000
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunfeng Li, Doctor
Phone:
18745787187
Email:
lichunfeng007@163.com
Investigator:
Last name:
Yingwei Xue, Doctor
Email:
Principal Investigator
Start date:
April 2014
Completion date:
June 2018
Lead sponsor:
Agency:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02269904
