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

March 16, 2018 updated by: Xiaodong Zhu, Fudan University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

215

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhu Xiaodong, MD
  • Phone Number: 86-21-64175590
  • Email: xddr001@163.com

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SOXP
Drug: Oxaliplatin
130mg/m2, d1, q3w
Drug: Paclitaxel
40mg/m2 ip，d1、8 ,q3w
Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)
40mg/m2 Bid po，d1-14,q3w
ACTIVE_COMPARATOR: SOX
Drug: Oxaliplatin
130mg/m2, d1, q3w
Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)
40mg/m2 Bid po，d1-14,q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 10 months
the internal between the date of enrollment and the date of death or last follow-up.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 16, 2018

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

March 16, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (ACTUAL)

March 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDZL-SOXP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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