Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

NCT ID: NCT00195572

Last Updated: 2009-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2008-08-31

Brief Summary

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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

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Isovorin

Intervention Type DRUG

TS-1

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Adachi-ku, Tokyo, , Japan

Site Status

Anjo, , Japan

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Aomori, , Japan

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Chiba, , Japan

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Chiba, , Japan

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Chikushino-shi, , Japan

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Fukuoka, , Japan

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Fukuroi-shi, , Japan

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Funai-gun, , Japan

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Hiroshima, , Japan

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Hiroshima, , Japan

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Ichihara-shi, , Japan

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Kanagawa, , Japan

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Kanazawa, , Japan

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Kisaradu-shi, , Japan

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Kitaadachi-gun, , Japan

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Koto-ku, Tokyo, , Japan

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Kyoto, , Japan

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Misawa-shi, , Japan

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Morioka, , Japan

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Nagasaki, , Japan

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Nagoya, , Japan

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Nagoya, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Ōmura, , Japan

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Saga, , Japan

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Sagamiharashi, , Japan

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Sapparo City, , Japan

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Sapporo, , Japan

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Sapporo, , Japan

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Sapporo, , Japan

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Sasebo-shi, , Japan

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Sendai, , Japan

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Sendai, , Japan

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Shizuka, , Japan

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Shizuoka, , Japan

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Sizuoka-shi, , Japan

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Takatuki-si, , Japan

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Tsuchiura-shi, , Japan

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Tsukuba, , Japan

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Uji-shi, , Japan

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Yamagata, , Japan

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Countries

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Japan

Other Identifiers

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ISO/5FU-10

Identifier Type: -

Identifier Source: org_study_id

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