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

Fudan University

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Epirubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02395640

FDZL-EXELOX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 438 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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438 participants in 2 patient groups

XELOX

Experimental group

Description:

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

Treatment:

Drug: Capecitabine

Drug: Oxaliplatin

EOX

Active Comparator group

Description:

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

Treatment:

Drug: Epirubicin

Drug: Capecitabine

Drug: Oxaliplatin