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Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00195572
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 13, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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).

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Isovorin Drug: TS-1 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Approved Phase III Study of 1-LV/5FU Therapy
Study Start Date : May 2002
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer




Primary Outcome Measures :
  1. Survival time

Secondary Outcome Measures :
  1. Response rate, duration of response, time to progression, safety, quality of life


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195572


Locations
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Japan
Adachi-ku, Tokyo, Japan, 123-0855
Anjo-city, Japan, 446-8602
Aomori-shi, Japan, 030-8553
Chiba-shi, Japan, 260-8717
Chiba, Japan, 260-8607
Chikushino-shi, Japan, 818-8502
Fukuoka, Japan, 812-8582
Fukuroi-shi, Japan, 437-0061
Funai-gun, Japan, 629-0392
Hiroshima-shi, Japan, 734-8551
Hiroshima, Japan, 730-8619
Ichihara-shi, Japan, 290-0003
Kanagawa, Japan, 224-8503
Kanazawa-shi, Japan, 920-8641
Kisaradu-shi, Japan, 292-8535
Kitaadachi-gun, Japan, 362-0806
Koto-ku, Tokyo, Japan, 135-8577
Kyoto, Japan, 602-8566
Misawa-shi, Japan, 033-0001
Morioka-shi, Japan, 020-8505
Nagasaki, Japan, 852-8501
Nagoya City, Japan, 458-0037
Nagoya, Japan, 464-8681
Oomura City, Japan, 856-8562
Osaka-si, Japan, 537-8511
Osaka-si, Japan, 545-8585
Sagamiharashi, Japan, 228-8520
Saga, Japan, 840-8571
Sapparo City, Japan, 064-0923
Sapporo City, Japan, 060-8543
Sapporo-shi, Japan, 003-8585
Sapporo-shi, Japan, 060-0001
Sasebo-shi, Japan, 857-8511
Sendai-shi, Japan, 983-8512
Sendai-shi, Japan, 983-8520
Shizuka, Japan, 432-8580
Shizuoka-shi, Japan, 420-8527
Sizuoka-shi, Japan, 420-8623
Takatuki-si, Japan, 569-8666
Tsuchiura-shi, Japan, 300-0053
Tsukuba-shi, Japan, 305-8576
Uji-shi, Japan, 611-0042
Yamagata-shi, Japan, 990-2292
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

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ClinicalTrials.gov Identifier: NCT00195572     History of Changes
Other Study ID Numbers: ISO/5FU-10
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 13, 2009
Last Verified: August 2009
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Gastric Cancer
Advanced/Recurrent Gastric Cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Levoleucovorin
Antidotes
Protective Agents
Physiological Effects of Drugs