Back to resultsThe Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Epirubicin
Oxaliplatin
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
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
Sites / Locations
- Fudan University Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
XELOX
EOX
Arm Description
oxaliplatin 130mg/m2 d1； capecitabine 1000mg/m2 Bid po，d1-14；
Epirubicin 50mg/m2 d1； oxaliplatin 130mg/m2 d1； capecitabine 1000mg/m2 Bid po，d1-14；
Outcomes
Primary Outcome Measures
progression free survival
Secondary Outcome Measures
overall survival
overall response rate
Number of Participants with Adverse Events
quality of life questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02395640
Brief Title
The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 23, 2021 (Actual)
Study Completion Date
February 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
438 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
XELOX
Arm Type
Experimental
Arm Description
oxaliplatin 130mg/m2 d1； capecitabine 1000mg/m2 Bid po，d1-14；
Arm Title
EOX
Arm Type
Active Comparator
Arm Description
Epirubicin 50mg/m2 d1； oxaliplatin 130mg/m2 d1； capecitabine 1000mg/m2 Bid po，d1-14；
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
50mg/m2 ivgtt d1
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
130mg/m2 ivgtt d1
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
1000mg/m2 po d1-14
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
7 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
10 months
Title
overall response rate
Time Frame
2 months
Title
Number of Participants with Adverse Events
Time Frame
2 months
Title
quality of life questionnaire
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
ShangHai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35212487
Citation
Zhu XD, Huang MZ, Wang YS, Feng WJ, Chen ZY, He YF, Zhang XW, Liu X, Wang CC, Zhang W, Ying JE, Wu J, Yang L, Qin YR, Luo JF, Zhao XY, Li WH, Zhang Z, Qiu LX, Geng QR, Zou JL, Zhang JY, Zheng H, Song XF, Wu SS, Zhang CY, Gong Z, Liu QQ, Wang XF, Xu Q, Wang Q, Ji JM, Zhao J, Guo WJ. XELOX doublet regimen versus EOX triplet regimen as first-line treatment for advanced gastric cancer: An open-labeled, multicenter, randomized, prospective phase III trial (EXELOX). Cancer Commun (Lond). 2022 Apr;42(4):314-326. doi: 10.1002/cac2.12278. Epub 2022 Feb 25.
Results Reference
derived
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The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer
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