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

NCT ID: NCT02395640

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

438 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2021-02-23

Brief Summary

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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

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XELOX

oxaliplatin 130mg/m2 d1; capecitabine 1000mg/m2 Bid po,d1-14;

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

Capecitabine

Intervention Type DRUG

1000mg/m2 po d1-14

EOX

Epirubicin 50mg/m2 d1; oxaliplatin 130mg/m2 d1; capecitabine 1000mg/m2 Bid po,d1-14;

Group Type ACTIVE_COMPARATOR

Epirubicin

Intervention Type DRUG

50mg/m2 ivgtt d1

Oxaliplatin

Intervention Type DRUG

Capecitabine

Intervention Type DRUG

1000mg/m2 po d1-14

Interventions

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Epirubicin

50mg/m2 ivgtt d1

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

Capecitabine

1000mg/m2 po d1-14

Intervention Type DRUG

Other Intervention Names

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130mg/m2 ivgtt d1 Xeloda

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Weijian Guo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 35212487 (View on PubMed)

Other Identifiers

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FDZL-EXELOX

Identifier Type: -

Identifier Source: org_study_id