Status:
UNKNOWN
A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites
Lead Sponsor:
Fudan University
Conditions:
Gastric Cancer
Stomach Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is designed to compare the efficacy of intraperitoneal paclitaxel in combination with SOX, with SOX alone in the first-line treatment of gastric cancer with malignant ascites
Eligibility Criteria
Inclusion
- had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic
- malignant ascites(over pelvic cavity in CT scan and confirmed by cytology)
- an Eastern Cooperative Oncology Group performance status of 0 to 2
- adequate renal, hepatic, and hematologic function
Exclusion
- previous chemotherapy or radiotherapy (unless in the adjuvant setting)
- uncontrolled cardiac disease, or other clinically significant, uncontrolled
- coexisting illness or previous or concurrent cancer
- HER2 positive and willing to use trastuzumab
Key Trial Info
Start Date :
March 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT03475615
Start Date
March 16 2018
End Date
December 31 2020
Last Update
March 23 2018
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, China, 200032