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Study Evaluating Isovorin in Colon Cancer

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NCT00195585

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Tokyo, , 104-0031 Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colon Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Dukes C, Cure A colon cancer diagnosed histologically or cytologically

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

- Age 20-75

Other inclusion applies

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

- Serious bone marrow suppression, infection, heart disease or complication

- Familial adenomatous polyposis or hereditary nonpolyposis

- Pregnant or breastfeeding women

Other exclusion applies

NCT00195585
Pfizer
Completed
Study Evaluating Isovorin in Colon Cancer

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[email protected]

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Study Evaluating Isovorin in Colon Cancer
Post-Approved Phase III Study of 1-LV/5FU Therapy
The purpose of the study is to verify superiority of 1-LV/5FU therapy to UFT Therapy of relapse-free survival time in patients with Dukes C and Cure A colon cancer. Secondary endpoints include disease-free survival time, survival time, and safety.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colon Cancer
  • Drug: Isovorin
  • Drug: UFT
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
650
February 2006
February 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Dukes C, Cure A colon cancer diagnosed histologically or cytologically
  • Normal organ function of bone marrow, heart, liver and kidney
  • Age 20-75

Other inclusion applies

Exclusion Criteria:

  • Serious bone marrow suppression, infection, heart disease or complication
  • Familial adenomatous polyposis or hereditary nonpolyposis
  • Pregnant or breastfeeding women

Other exclusion applies
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00195585
ISO/5FU-11
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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