A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03475615
• Other study ID #: FDZL-SOXP
• Status: Recruiting
• Phase: Phase 3
• First received: March 16, 2018
• Last updated: March 16, 2018
• Start date: March 16, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2018
• Source: Fudan University
• Contact: Zhu Xiaodong, MD
• Phone: 86-21-64175590
• Email: xddr001[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 215
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	the internal between the date of enrollment and the date of death or last follow-up.	10 months