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NCT01285557 · ClinicalTrials.gov registry record · Phase 3
Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial
A Phase 3 study, sponsored by Taiho Oncology.
- Terminated
- Registry status
- Phase 3
- Development phase
- 361
- Enrollment target
NCT01285557: Clinical Trial Phase 3 study, sponsored by Taiho Oncology.
NCT01285557 is a Phase 3 study that was terminated before completion, run by Taiho Oncology. The registered enrollment target is 361 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01285557, a Phase 3 study, was terminated before completion, sponsored by Taiho Oncology.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 361 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and gastro-esophageal junction cancer previously untreated with chemotherapy.
Primary Outcome
OS was defined as the time from randomization to the date of death for the ITT population. Participants who did not die were censored at the date last known to be alive. Analysis was performed by using Kaplan-Meier method.
Interventions
- DRUG S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm)
- DRUG Fluorouracil/cisplatin (control arm)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 361 participants |
| Start Date | 2011-04-14 |
| Est. Completion | 2014-08-15 |
| Phase | Phase 3 |
Why NCT01285557 stopped before completion
NCT01285557 is an interventional study that assigns participants to a tested intervention. The registered 361 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm) is the first listed.
NCT01285557 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01285557 about?
NCT01285557 is a clinical study titled "Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial". The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and gastro-esophageal junction cancer previously untreated with chemotherapy.
What is the current status of trial NCT01285557?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 361 participants. The study started on 2011-04-14. Estimated completion is 2014-08-15.
What interventions are being tested in trial NCT01285557?
The interventions under investigation include: S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm) (DRUG), Fluorouracil/cisplatin (control arm) (DRUG).
Who is sponsoring clinical trial NCT01285557?
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 NCT01285557's enrollment target sits among peer trials
361 1008th of 2000 higher than 993 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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