A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites
NCT ID: NCT03475615
Last Updated: 2018-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
215 participants
INTERVENTIONAL
2018-03-16
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SOXP
Oxaliplatin
130mg/m2, d1, q3w
Paclitaxel
40mg/m2 ip，d1、8 ,q3w
S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)
40mg/m2 Bid po，d1-14,q3w
SOX
Oxaliplatin
130mg/m2, d1, q3w
S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)
40mg/m2 Bid po，d1-14,q3w
Interventions
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Oxaliplatin
130mg/m2, d1, q3w
Paclitaxel
40mg/m2 ip，d1、8 ,q3w
S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)
40mg/m2 Bid po，d1-14,q3w
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* uncontrolled cardiac disease, or other clinically significant, uncontrolled
* coexisting illness or previous or concurrent cancer
* HER2 positive and willing to use trastuzumab
18 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xiaodong Zhu
MD
Locations
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Fudan University Cancer Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FDZL-SOXP
Identifier Type: -
Identifier Source: org_study_id
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