NCT00195572

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 gastric-cancer

Timeline
Completed

Started May 2002

Typical duration for phase_3 gastric-cancer

Geographic Reach
1 country

43 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 13, 2009

Status Verified

August 1, 2009

Enrollment Period

6.3 years

First QC Date

September 12, 2005

Last Update Submit

August 12, 2009

Conditions

Gastric Cancer

Keywords

Gastric CancerAdvanced/Recurrent Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Survival time

Secondary Outcomes (1)

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

Interventions

IsovorinDRUG
TS-1DRUG

Eligibility Criteria

Age20 Years - 77 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gastric cancer diagnosed histologically or cytologically
  • Normal organ function of bone marrow, heart, liver and kidney
  • Age of 20-77

You may not qualify if:

  • Serious infection, heart disease, complication or organ disorder
  • Ongoing administration of flucytosine
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (43)

Unknown Facility

Adachi-ku, Tokyo, 123-0855, Japan

Location

Unknown Facility

Anjo, 446-8602, Japan

Location

Unknown Facility

Aomori, 030-8553, Japan

Location

Unknown Facility

Chiba, 260-8607, Japan

Location

Unknown Facility

Chiba, 260-8717, Japan

Location

Unknown Facility

Chikushino-shi, 818-8502, Japan

Location

Unknown Facility

Fukuoka, 812-8582, Japan

Location

Unknown Facility

Fukuroi-shi, 437-0061, Japan

Location

Unknown Facility

Funai-gun, 629-0392, Japan

Location

Unknown Facility

Hiroshima, 730-8619, Japan

Location

Unknown Facility

Hiroshima, 734-8551, Japan

Location

Unknown Facility

Ichihara-shi, 290-0003, Japan

Location

Unknown Facility

Kanagawa, 224-8503, Japan

Location

Unknown Facility

Kanazawa, 920-8641, Japan

Location

Unknown Facility

Kisaradu-shi, 292-8535, Japan

Location

Unknown Facility

Kitaadachi-gun, 362-0806, Japan

Location

Unknown Facility

Koto-ku, Tokyo, 135-8577, Japan

Location

Unknown Facility

Kyoto, 602-8566, Japan

Location

Unknown Facility

Misawa-shi, 033-0001, Japan

Location

Unknown Facility

Morioka, 020-8505, Japan

Location

Unknown Facility

Nagasaki, 852-8501, Japan

Location

Unknown Facility

Nagoya, 458-0037, Japan

Location

Unknown Facility

Nagoya, 464-8681, Japan

Location

Unknown Facility

Osaka, 537-8511, Japan

Location

Unknown Facility

Osaka, 545-8585, Japan

Location

Unknown Facility

Ōmura, 856-8562, Japan

Location

Unknown Facility

Saga, 840-8571, Japan

Location

Unknown Facility

Sagamiharashi, 228-8520, Japan

Location

Unknown Facility

Sapparo City, 064-0923, Japan

Location

Unknown Facility

Sapporo, 003-8585, Japan

Location

Unknown Facility

Sapporo, 060-0001, Japan

Location

Unknown Facility

Sapporo, 060-8543, Japan

Location

Unknown Facility

Sasebo-shi, 857-8511, Japan

Location

Unknown Facility

Sendai, 983-8512, Japan

Location

Unknown Facility

Sendai, 983-8520, Japan

Location

Unknown Facility

Shizuka, 432-8580, Japan

Location

Unknown Facility

Shizuoka, 420-8527, Japan

Location

Unknown Facility

Sizuoka-shi, 420-8623, Japan

Location

Unknown Facility

Takatuki-si, 569-8666, Japan

Location

Unknown Facility

Tsuchiura-shi, 300-0053, Japan

Location

Unknown Facility

Tsukuba, 305-8576, Japan

Location

Unknown Facility

Uji-shi, 611-0042, Japan

Location

Unknown Facility

Yamagata, 990-2292, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Leucovorintitanium silicide

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

FormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and Coenzymes

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

May 1, 2002

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 13, 2009

Record last verified: 2009-08

Locations

JP(43)