Status:

COMPLETED

Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Gastric Cancer

Eligibility:

All Genders

20-77 years

Phase:

PHASE3

Brief Summary

The purpose of the study is to verify non-inferiority of survival time between Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable advanced or recurrent gastric can...

Eligibility Criteria

Inclusion

  • Gastric cancer diagnosed histologically or cytologically
  • Normal organ function of bone marrow, heart, liver and kidney
  • Age of 20-77
  • Other inclusion applies

Exclusion

  • Serious infection, heart disease, complication or organ disorder
  • Ongoing administration of flucytosine
  • Pregnant or breastfeeding women
  • Other exclusion applies

Key Trial Info

Start Date :

May 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2008

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT00195572

Start Date

May 1 2002

End Date

August 1 2008

Last Update

August 13 2009

Active Locations (43)

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Page 1 of 11 (43 locations)

1

Adachi-ku, Tokyo, Japan, 123-0855

2

Anjo, Japan, 446-8602

3

Aomori, Japan, 030-8553

4

Chiba, Japan, 260-8607