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NCT02030574 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Gemcitabine and Fractionated, Weekly Cisplatin For Muscle Invasive Bladder Cancer and Patients Not Candidates For High Dose Cisplatin
A Phase 2 study, sponsored by Brown University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT02030574: Clinical Trial Phase 2 study, sponsored by Brown University.
NCT02030574 is a Phase 2 study that was terminated before completion, run by Brown University. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02030574, a Phase 2 study, was terminated before completion, sponsored by Brown University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
The standard treatment of muscle invasive bladder cancer is to administer chemotherapy for approximately 3 months then to have surgery to remove the bladder. Chemotherapy may reduce the size of the cancer in your bladder before surgery and can also help to reduce the chance that your bladder cancer will come back (metastasize) in other parts of your body after bladder surgery. This study will involve testing cisplatin in lower weekly doses with gemcitabine.The purpose of this study is to test the effects, good and bad, of low dose weekly cisplatin and gemcitabine.
Primary Outcome
Response will be evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 \[Eur J Cancer. 2009;45:228-247.\].Complete Response (CR): Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baselin
Interventions
- DRUG Gemcitabine and fractionated cisplatin (combination treatment)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2014-07 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
Why NCT02030574 stopped before completion
NCT02030574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Gemcitabine and fractionated cisplatin (combination treatment) is the first listed.
NCT02030574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02030574 about?
NCT02030574 is a clinical study titled "Neoadjuvant Gemcitabine and Fractionated, Weekly Cisplatin For Muscle Invasive Bladder Cancer and Patients Not Candidates For High Dose Cisplatin". The standard treatment of muscle invasive bladder cancer is to administer chemotherapy for approximately 3 months then to have surgery to remove the bladder. Chemotherapy may reduce the size of the cancer in your bladder before surgery and can also help to reduce the chance that your bladder cancer ...
What is the current status of trial NCT02030574?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2014-07. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02030574?
The interventions under investigation include: Gemcitabine and fractionated cisplatin (combination treatment) (DRUG).
Who is sponsoring clinical trial NCT02030574?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02030574's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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