The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer

October 18, 2021 updated by: Weijian Guo, Fudan University

The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer: An Open-label, Multi-center, Prospective and Randomised Study

This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.

Study Type

Interventional

Enrollment (Anticipated)

438

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 Locations

  • China
    • Shanghai
      • ShangHai, Shanghai, China, 200032
        • Fudan University Cancer Hospital

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Major inclusion criteria

  • had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic
  • measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)1.1
  • an Eastern Cooperative Oncology Group performance status of 0 to 2
  • adequate renal, hepatic, and hematologic function

Major 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
  • accumulated dose of Epirubicin exceeds 300mg/m2
  • 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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XELOX
oxaliplatin 130mg/m2 d1； capecitabine 1000mg/m2 Bid po，d1-14；
Drug: Oxaliplatin
Other Names:
  • 130mg/m2 ivgtt d1
Drug: Capecitabine
1000mg/m2 po d1-14
Other Names:
  • Xeloda
Active Comparator: EOX
Epirubicin 50mg/m2 d1； oxaliplatin 130mg/m2 d1； capecitabine 1000mg/m2 Bid po，d1-14；
Drug: Oxaliplatin
Other Names:
  • 130mg/m2 ivgtt d1
Drug: Capecitabine
1000mg/m2 po d1-14
Other Names:
  • Xeloda
Drug: Epirubicin
50mg/m2 ivgtt d1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: 7 months
7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall response rate
Time Frame: 2 months
2 months
Number of Participants with Adverse Events
Time Frame: 2 months
2 months
quality of life questionnaire
Time Frame: 2 months
2 months
overall survival
Time Frame: 10 months
10 months

Collaborators and Investigators

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

Sponsor

Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2015

Primary Completion (Actual)

February 23, 2021

Study Completion (Actual)

February 23, 2021

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 23, 2015

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDZL-EXELOX

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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