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NCT00400179 · ClinicalTrials.gov registry record · Phase 3
A Safety and Efficacy Study in Patients With Gastric Cancer
A Phase 3 study, sponsored by Taiho Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,053
- Enrollment target
NCT00400179: Completed Phase 3 study, sponsored by Taiho Oncology.
NCT00400179 is a Phase 3 study that has completed, run by Taiho Oncology. The registered enrollment target is 1,053 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00400179, a Phase 3 study, has completed, sponsored by Taiho Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,053 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Survival was defined as the time from the date of randomization to the time of death (from any cause) for each patient.
Interventions
- DRUG S-1/Cisplatin
- DRUG 5-FU/cisplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,053 participants |
| Start Date | 2005-05 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
What the finished NCT00400179 record still lists
NCT00400179 is an interventional study that assigns participants to a tested intervention. Its 1,053 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% higher).
The record links to 0 conditions, and to 2 interventions - of which S-1/Cisplatin is the first listed.
NCT00400179 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00400179 about?
NCT00400179 is a clinical study titled "A Safety and Efficacy Study in Patients With Gastric Cancer". 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) ...
What is the current status of trial NCT00400179?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,053 participants. The study started on 2005-05. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00400179?
The interventions under investigation include: S-1/Cisplatin (DRUG), 5-FU/cisplatin (DRUG).
Who is sponsoring clinical trial NCT00400179?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00400179's enrollment target sits among peer trials
1,053 278th of 2000 higher than 1,723 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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