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

This study has been completed.
Information provided by:
Samsung Medical Center Identifier:
First received: August 27, 2008
Last updated: January 13, 2010
Last verified: January 2010
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.

Condition Intervention Phase
Advanced Gastric Cancer
Drug: Epirubicin
Drug: Cisplatin, capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Combination Chemotherapy With Epirubicin , Cisplatin and Capecitabine (ECX) or Cisplatin and Capecitabine (CX) in Advanced Gastric Cancer

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Failure-free survival [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression-free survival [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: April 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ECX
Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.
Drug: Epirubicin
Epirubicin 50 mg/m2 iv on day 1
Drug: Cisplatin, capecitabine
Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.
Active Comparator: CX
Cisplatin and capecitabine combination chemotherapy will be administered.
Drug: Cisplatin, capecitabine
Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.


Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00743964

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135 710
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided by Samsung Medical Center

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Se Hoon Park, MD, Samsung Medical Center Identifier: NCT00743964     History of Changes
Other Study ID Numbers: SMC IRB 2008-04-027, 01-9-0804027
Study First Received: August 27, 2008
Last Updated: January 13, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Site
Stomach Diseases
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on November 25, 2015