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NCT01261728 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma
A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT01261728: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01261728 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01261728, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin for four 21 day cycles for a total of 12 weeks can help shrink the tumor before undergoing surgery for kidney cancer.
Primary Outcome
of neoadjuvant Gemcitabine and Cisplatin/GC regimen in patients with upper tract high-grade urothelial carcinoma. Pathologic response to neoadjuvant GC is defined as the absence of high-grade carcinoma (\<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final nephroureterectomy specimen.
Interventions
- DRUG Gemcitabine and Cisplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2010-12-14 |
| Est. Completion | 2025-08-06 |
| Phase | Phase 2 |
What the finished NCT01261728 record still lists
NCT01261728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Gemcitabine and Cisplatin is the first listed.
NCT01261728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01261728 about?
NCT01261728 is a clinical study titled "Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma". The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin for four 21 day cycles for a total of 12 weeks can help shrink the tumor before undergoing surgery for kidney cancer.
What is the current status of trial NCT01261728?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2010-12-14. Estimated completion is 2025-08-06.
What interventions are being tested in trial NCT01261728?
The interventions under investigation include: Gemcitabine and Cisplatin (DRUG).
Who is sponsoring clinical trial NCT01261728?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01261728's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 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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