Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

NCT00195572

Last updated date
Study Location
Adachi-ku, Tokyo, , 123-0855, Japan
Contact
1-800-718-1021

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[email protected]

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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

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Gastric CancerStudy Evaluating Isovorin in Advanced/Recurrent Gastric Cancer
NCT00195572
  1. Adachi-ku, Tokyo,
  2. Anjo-city,
  3. Aomori-shi,
  4. Chiba-shi,
  5. Chiba,
  6. Chikushino-shi,
  7. Fukuoka,
  8. Fukuroi-shi,
  9. Funai-gun,
  10. Hiroshima-shi,
  11. Hiroshima,
  12. Ichihara-shi,
  13. Kanagawa,
  14. Kanazawa-shi,
  15. Kisaradu-shi,
  16. Kitaadachi-gun,
  17. Koto-ku, Tokyo,
  18. Kyoto,
  19. Misawa-shi,
  20. Morioka-shi,
  21. Nagasaki,
  22. Nagoya City,
  23. Nagoya,
  24. Oomura City,
  25. Osaka-si,
  26. Osaka-si,
  27. Sagamiharashi,
  28. Saga,
  29. Sapparo City,
  30. Sapporo City,
  31. Sapporo-shi,
  32. Sapporo-shi,
  33. Sasebo-shi,
  34. Sendai-shi,
  35. Sendai-shi,
  36. Shizuka,
  37. Shizuoka-shi,
  38. Sizuoka-shi,
  39. Takatuki-si,
  40. Tsuchiura-shi,
  41. Tsukuba-shi,
  42. Uji-shi,
  43. Yamagata-shi,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer
Official Title  ICMJE Post-Approved Phase III Study of 1-LV/5FU Therapy
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 cancer. Secondary endpoints include response rates, duration of responses, time to progression (TTP) safety and quality of life (QOL).
Detailed Description Not 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 Gastric Cancer
Intervention  ICMJE
  • Drug: Isovorin
  • Drug: TS-1
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
Estimated Enrollment  ICMJE
 (submitted: September 15, 2005)
200
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 77 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 NCT00195572
Other Study ID Numbers  ICMJE ISO/5FU-10
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not 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 Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP