Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

August 12, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Adachi-ku, Tokyo, Japan, 123-0855
      • Anjo-city, Japan, 446-8602
      • Aomori-shi, Japan, 030-8553
      • Chiba, Japan, 260-8607
      • Chiba-shi, Japan, 260-8717
      • Chikushino-shi, Japan, 818-8502
      • Fukuoka, Japan, 812-8582
      • Fukuroi-shi, Japan, 437-0061
      • Funai-gun, Japan, 629-0392
      • Hiroshima, Japan, 730-8619
      • Hiroshima-shi, Japan, 734-8551
      • 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, Japan, 464-8681
      • Nagoya City, Japan, 458-0037
      • Oomura City, Japan, 856-8562
      • Osaka-si, Japan, 537-8511
      • Osaka-si, Japan, 545-8585
      • Saga, Japan, 840-8571
      • Sagamiharashi, Japan, 228-8520
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival time

Secondary Outcome Measures

Outcome Measure
Response rate, duration of response, time to progression, safety, quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

August 13, 2009

Last Update Submitted That Met QC Criteria

August 12, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISO/5FU-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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