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

Phase 3

• Conditions: Gastric Cancer; Stomach Neoplasms
• Interventions: Drug: Oxaliplatin; Drug: Paclitaxel; Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)

• Registration Number: NCT03475615
• Lead Sponsor: Fudan University

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-03
• Study Start: 2018-03-16
• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-03-16
• Last Update Submitted: 2018-03-16
• Study First Posted: 2018-03-23
• Last Update Posted: 2018-03-23
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 215

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOXP	S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)	-
SOX	S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)	-
SOXP	Oxaliplatin	-
SOXP	Paclitaxel	-
SOX	Oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
overall survival	10 months	the internal between the date of enrollment and the date of death or last follow-up.

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, China