Phase II Study of Epirubicin, Cisplatin and Capecitabine (ECX) Versus Cisplatin and Capecitabine (CX) for Advanced Gastric Cancer (AGC)

A Randomized Phase II Study of Combination Chemotherapy With Epirubicin , Cisplatin and Capecitabine (ECX) or Cisplatin and Capecitabine (CX) in Advanced Gastric Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00743964

Enrollment

Registered

2008-08-29

Start date

2008-04-30

Completion date

2009-10-31

Last updated

2010-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Gastric Cancer

Brief summary

Recently, 3-drug (ECX) and 2-drug (CX) combination chemotherapy involving capecitabine showed promising results in randomized clinical trials for advanced gastric cancer (AGC). The objective of the study is to evaluate the safety and activity of ECX and CX combination chemotherapy given as first-line therapy for AGC.

Interventions

DRUGEpirubicin

Epirubicin 50 mg/m2 iv on day 1

DRUGCisplatin, capecitabine

Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 75 Years

Healthy volunteers

Inclusion criteria

* Aged 75 years or less * Adenocarcinoma of stomach * Advanced, metastatic, or recurrent * No prio chemotherapy for advanced disease * Adequate performance status * Adequate major organ functions

Exclusion criteria

* Severe comorbid illness or active infections * Pregnancy or lactating women * GI obstruction or malabsorption syndrome

Design outcomes

Primary

Measure	Time frame
Failure-free survival	six months

Secondary

Measure	Time frame
progression-free survival	six months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026