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

Fudan University215 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

215

Conditions

Gastric Cancer Stomach Neoplasms

Interventions

OxaliplatinDRUG

130mg/m2, d1, q3w

PaclitaxelDRUG

40mg/m2 ip，d1、8 ,q3w

S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)DRUG

40mg/m2 Bid po，d1-14,q3w

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Fudan University Cancer Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

overall survival

the internal between the date of enrollment and the date of death or last follow-up.

Time frame: 10 months

Central Contacts

Zhu Xiaodong, MD

CONTACT

86-21-64175590 xddr001@163.com

Data from ClinicalTrials.gov

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