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Study Evaluating Isovorin in Colon Cancer

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
Tokyo, , 104-0031 Japan
Contact
1-800-718-1021
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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Descriptive Information
Brief Title  ICMJE Study Evaluating Isovorin in Colon Cancer
Official Title  ICMJE Post-Approved Phase III Study of 1-LV/5FU Therapy
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE
  • Drug: Isovorin
  • Drug: UFT
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 15, 2005)
650
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2006
Actual Primary Completion DateFebruary 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00195585
Other Study ID Numbers  ICMJE ISO/5FU-11
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateAugust 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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