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NCT Number: NCT02395640

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epirubicin

Drug

50mg/m2 ivgtt d1

Oxaliplatin

Drug

Other names: 130mg/m2 ivgtt d1

Capecitabine

Drug

1000mg/m2 po d1-14

Other names: Xeloda

Primary outcomes

  1. progression free survival

    Time frame: 7 months

Secondary outcomes

  1. overall survival

    Time frame: 10 months

  2. overall response rate

    Time frame: 2 months

  3. Number of Participants with Adverse Events

    Time frame: 2 months

  4. quality of life questionnaire

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2015
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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