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

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: Advanced Gastric Cancer

Treatments: Drug: Cisplatin, capecitabine; Drug: Epirubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT00743964

01-9-0804027

SMC IRB 2008-04-027

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: Under 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

ECX

Experimental group

Description:

Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.

Treatment:

Drug: Epirubicin

Drug: Cisplatin, capecitabine

CX

Active Comparator group

Description:

Cisplatin and capecitabine combination chemotherapy will be administered.

Treatment:

Drug: Cisplatin, capecitabine