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OpenTrials
Completed

NCT Number: NCT00743964

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

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.

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Key information

Conditions

Advanced Gastric Cancer

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Samsung Medical Center

Seoul, 135 710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epirubicin

Drug

Epirubicin 50 mg/m2 iv on day 1

cisplatin, capecitabine

Drug

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

Primary outcomes

  1. Failure-free survival

    Time frame: six months

Secondary outcomes

  1. progression-free survival

    Time frame: six months

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 29, 2008
Registry last updated
Jan 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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