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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 is a Phase 3 study that has completed, run by Taiho Oncology. The registered enrollment target is 1,053 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00400179
The ClinicalTrials.gov registry entry for NCT00400179 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,053 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taiho Oncology, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which S-1/Cisplatin is the first listed.
NCT00400179 reports 0 study locations.
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.
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