Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Post-Approved Phase III Study of 1-LV/5FU Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195572
• Other study ID #: ISO/5FU-10
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: August 12, 2009
• Start date: May 2002
• Est. completion date: August 2008

Study information

• Verified date: August 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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 cancer. Secondary endpoints include response rates, duration of responses, time to progression (TTP) safety and quality of life (QOL).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 77 Years

Eligibility

Inclusion Criteria:

• Gastric cancer diagnosed histologically or cytologically

• Normal organ function of bone marrow, heart, liver and kidney

• Age of 20-77

Other inclusion applies

Exclusion Criteria:

• Serious infection, heart disease, complication or organ disorder

• Ongoing administration of flucytosine

• Pregnant or breastfeeding women

Other exclusion applies

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Isovorin

• TS-1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival time
Secondary	Response rate, duration of response, time to progression, safety, quality of life