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NCT01589094 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer
A Phase 2 study of Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 8
- Study locations
NCT01589094: Completed Phase 2 study of Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01589094 is a Phase 2 study of Bladder Cancer that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 51 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 8 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01589094, a Phase 2 study of Bladder Cancer, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to find out if standard chemotherapy (gemcitabine and cisplatin) given on a dose-dense treatment schedule (with less time between treatments) can help shrink the tumor better than standard chemotherapy given on a standard treatment schedule before the patient undergoes surgery for bladder cancer.
Primary Outcome
Defined as the absence of muscle invasive carcinoma (\<pT2 disease) and the absence of lymph node metastases (N0) on the final cystectomy specimen. Pathologists will assess surgical specimens systematically using criteria agreed upon for all conventional neoadjuvant treatment based on the AJCC TNM staging system.
Conditions Studied
Interventions
- DRUG Gemcitabine and Cisplatin (DD GC)
Study Locations (8)
New York
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack
- Memorial Sloan Kettering West Harrison - Harrison
- New York University - New York
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Cancer Center at Mercy Medical Center - Rockville Centre
- Memoral Sloan Kettering Cancer Center@Phelps - Sleepy Hollow
New Jersey
- Memorial Sloan Kettering at Basking Ridge - Basking Ridge
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2012-04 |
| Est. Completion | 2018-08 |
| Phase | Phase 2 |
What the finished NCT01589094 record still lists
NCT01589094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which Gemcitabine and Cisplatin (DD GC) is the first listed.
NCT01589094 lists 8 locations in 3 states (New York, New Jersey, North Carolina).
Frequently Asked Questions
What is clinical trial NCT01589094 about?
NCT01589094 is a clinical study titled "Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer". The purpose of this study is to find out if standard chemotherapy (gemcitabine and cisplatin) given on a dose-dense treatment schedule (with less time between treatments) can help shrink the tumor better than standard chemotherapy given on a standard treatment schedule before the patient undergoes s...
What is the current status of trial NCT01589094?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2012-04. Estimated completion is 2018-08.
What conditions does trial NCT01589094 study?
This clinical trial studies the following conditions: Bladder Cancer.
What interventions are being tested in trial NCT01589094?
The interventions under investigation include: Gemcitabine and Cisplatin (DD GC) (DRUG).
Who is sponsoring clinical trial NCT01589094?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01589094 being conducted?
This trial has 8 study locations across New Jersey, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01589094's enrollment target sits among peer trials
51 113th of 175 higher than 63 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer 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.
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