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Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Adachi-ku, Tokyo, , 123-0855 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastric Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-77 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Serious infection, heart disease, complication or organ disorder

- Ongoing administration of flucytosine

- Pregnant or breastfeeding women

Other exclusion applies

NCT00195572
Pfizer
Completed
Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

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Similar Trials

Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer
Post-Approved Phase III Study of 1-LV/5FU Therapy
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastric Cancer
  • Drug: Isovorin
  • Drug: TS-1
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
August 2008
August 2008   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
20 Years to 77 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00195572
ISO/5FU-10
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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