Back to resultsA Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites
Primary Purpose
Gastric Cancer, Stomach Neoplasms
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin
Paclitaxel
S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Fudan University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SOXP
SOX
Arm Description
Outcomes
Primary Outcome Measures
overall survival
the internal between the date of enrollment and the date of death or last follow-up.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03475615
Brief Title
A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites
Official Title
A Randomized Study of the Effect of First-line Intraperitoneal Paclitaxel in Combination With SOX Versus SOX Alone in Gastric Cancer Patients With Malignant Ascites
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Stomach Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
215 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SOXP
Arm Type
Experimental
Arm Title
SOX
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130mg/m2, d1, q3w
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
40mg/m2 ip，d1、8 ,q3w
Intervention Type
Drug
Intervention Name(s)
S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)
Intervention Description
40mg/m2 Bid po，d1-14,q3w
Primary Outcome Measure Information:
Title
overall survival
Description
the internal between the date of enrollment and the date of death or last follow-up.
Time Frame
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhu Xiaodong, MD
Phone
86-21-64175590
Email
xddr001@163.com
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaodong Zhu, M.D
Phone
862164175590
Ext
1105
Email
xddr001@163.com
First Name & Middle Initial & Last Name & Degree
xiaodong Zhu, M.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites
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