drugset / Trial / NCT02269904
Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2014-04
- Primary completion
- 2018-04
- Completion
- 2018-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | fluorouracil | Small molecule | 800 mg | Other |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
Indications
No indication recorded.