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Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Isovorin
TS-1
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Advanced/Recurrent Gastric Cancer

Eligibility Criteria

20 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Survival time

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
August 12, 2009
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00195572
Brief Title
Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer
Official Title
Post-Approved Phase III Study of 1-LV/5FU Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric Cancer, Advanced/Recurrent Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Isovorin
Intervention Type
Drug
Intervention Name(s)
TS-1
Primary Outcome Measure Information:
Title
Survival time
Secondary Outcome Measure Information:
Title
Response rate, duration of response, time to progression, safety, quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Adachi-ku, Tokyo
ZIP/Postal Code
123-0855
Country
Japan
City
Anjo-city
ZIP/Postal Code
446-8602
Country
Japan
City
Aomori-shi
ZIP/Postal Code
030-8553
Country
Japan
City
Chiba-shi
ZIP/Postal Code
260-8717
Country
Japan
City
Chiba
ZIP/Postal Code
260-8607
Country
Japan
City
Chikushino-shi
ZIP/Postal Code
818-8502
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Fukuroi-shi
ZIP/Postal Code
437-0061
Country
Japan
City
Funai-gun
ZIP/Postal Code
629-0392
Country
Japan
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
City
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
City
Ichihara-shi
ZIP/Postal Code
290-0003
Country
Japan
City
Kanagawa
ZIP/Postal Code
224-8503
Country
Japan
City
Kanazawa-shi
ZIP/Postal Code
920-8641
Country
Japan
City
Kisaradu-shi
ZIP/Postal Code
292-8535
Country
Japan
City
Kitaadachi-gun
ZIP/Postal Code
362-0806
Country
Japan
City
Koto-ku, Tokyo
ZIP/Postal Code
135-8577
Country
Japan
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
City
Misawa-shi
ZIP/Postal Code
033-0001
Country
Japan
City
Morioka-shi
ZIP/Postal Code
020-8505
Country
Japan
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
City
Nagoya City
ZIP/Postal Code
458-0037
Country
Japan
City
Nagoya
ZIP/Postal Code
464-8681
Country
Japan
City
Oomura City
ZIP/Postal Code
856-8562
Country
Japan
City
Osaka-si
ZIP/Postal Code
537-8511
Country
Japan
City
Osaka-si
ZIP/Postal Code
545-8585
Country
Japan
City
Sagamiharashi
ZIP/Postal Code
228-8520
Country
Japan
City
Saga
ZIP/Postal Code
840-8571
Country
Japan
City
Sapparo City
ZIP/Postal Code
064-0923
Country
Japan
City
Sapporo City
ZIP/Postal Code
060-8543
Country
Japan
City
Sapporo-shi
ZIP/Postal Code
003-8585
Country
Japan
City
Sapporo-shi
ZIP/Postal Code
060-0001
Country
Japan
City
Sasebo-shi
ZIP/Postal Code
857-8511
Country
Japan
City
Sendai-shi
ZIP/Postal Code
983-8512
Country
Japan
City
Sendai-shi
ZIP/Postal Code
983-8520
Country
Japan
City
Shizuka
ZIP/Postal Code
432-8580
Country
Japan
City
Shizuoka-shi
ZIP/Postal Code
420-8527
Country
Japan
City
Sizuoka-shi
ZIP/Postal Code
420-8623
Country
Japan
City
Takatuki-si
ZIP/Postal Code
569-8666
Country
Japan
City
Tsuchiura-shi
ZIP/Postal Code
300-0053
Country
Japan
City
Tsukuba-shi
ZIP/Postal Code
305-8576
Country
Japan
City
Uji-shi
ZIP/Postal Code
611-0042
Country
Japan
City
Yamagata-shi
ZIP/Postal Code
990-2292
Country
Japan

12. IPD Sharing Statement

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Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

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