A Safety and Efficacy Study in Patients With Gastric Cancer
Public ClinicalTrials.gov record NCT00400179. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
An Open-Label Multicenter, Randomized, Phase 3 Study of S-1 in Combination With Cisplatin Against 5-Fu in Combination W/ Cisplatin in Patients W/ Advanced Gastric Cancer Previously Untreated W/ Chemotherapy for Advanced Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1) to S-1/cisplatin (experimental arm) or 5-FU/cisplatin (control arm). Patients will be stratified by number of metastatic sites (one vs. more than one), locally advanced or metastatic disease, prior adjuvant therapy (yes or no), measurable or non-measurable disease, and center.
Study identification
- NCT ID
- NCT00400179
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,053 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2005 (Type not available)
- Primary completion
- Mar 2008 (Actual)
- Completion
- Apr 2008 (Actual)
- Last update posted
- Sep 19, 2024
2005 – 2008
United States locations
- U.S. sites
- 32
- U.S. states
- 18
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clearview Cancer Center | Huntsville | Alabama | 35801 | — |
| Saint Joseph Medical Center | Burbank | California | 91505 | — |
| Dr. Ronald Yanagihara | Gilroy | California | 95020 | — |
| Norris Cancer Center | Los Angeles | California | 90033 | — |
| Comprehensive Cancer Center | Palm Springs | California | 92262 | — |
| Saint Francis Memorial Hospital | San Francisco | California | 94109 | — |
| Premiere Oncology | Santa Monica | California | 90404 | — |
| Western Hematology/Oncology | Lakewood | Colorado | 80215 | — |
| Broward Oncology Associates | Fort Lauderdale | Florida | 33308 | — |
| Alexandar Rosemurgy | Tampa | Florida | 33606 | — |
| Palm Beach Cancer Institute | West Palm Beach | Florida | 33401 | — |
| Straub Clinic and Hospital | Honolulu | Hawaii | 96813 | — |
| Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 60611 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637-1470 | — |
| Oncology and Hematology | Metairie | Louisiana | 70006 | — |
| St. Lukes Cancer Care Center | Duluth | Minnesota | 55802 | — |
| Neuroscience Center | St Louis | Missouri | 63110 | — |
| St. Louis University Cancer Center | St Louis | Missouri | 63110 | — |
| Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | — |
| AHS Lovelace Medical Group,LLC | Albuquerque | New Mexico | 87102 | — |
| New Mexico Cancer Center Associates | Albuquerque | New Mexico | 87106 | — |
| University of New Mexico | Albuquerque | New Mexico | 87106 | — |
| Hoo Chun, MD | Hawthorne | New York | 10532 | — |
| Hematology/Oncology Associates of Rockland | New City | New York | 10956 | — |
| New Bern Cancer Care | New Bern | North Carolina | 28560 | — |
| Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Charleston Cancer Center | Charleston | South Carolina | 29406 | — |
| Associates in Oncology and Hematology | Chattanooga | Tennessee | 37404 | — |
| Lexington Oncology Associates | Chattanooga | Tennessee | 37404 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00400179, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 19, 2024 · Synced Nov 9, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00400179 live on ClinicalTrials.gov.