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

Samsung Medical Center91 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Gastric Cancer

Interventions

EpirubicinDRUG

Epirubicin 50 mg/m2 iv on day 1

Cisplatin, capecitabineDRUG

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

Eligibility

Sex: ALLMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Failure-free survival

Time frame: six months

Secondary Outcomes

progression-free survival

Time frame: six months

Data from ClinicalTrials.gov

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