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NCT03609216 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations
A Phase 2 study of Infiltrating Bladder Urothelial Carcinoma and Stage II Bladder Urothelial Carcinoma, sponsored by Alliance for Clinical Trials in Oncology.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 271
- Enrollment target
- 20
- Study locations
NCT03609216: Recruiting Phase 2 study of Infiltrating Bladder Urothelial Carcinoma and Stage II Bladder Urothelial Carcinoma, sponsored by Alliance for Clinical Trials in Oncology.
NCT03609216 is a Phase 2 study of Infiltrating Bladder Urothelial Carcinoma and Stage II Bladder Urothelial Carcinoma that is actively recruiting participants, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 271 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (104% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03609216, a Phase 2 study of Infiltrating Bladder Urothelial Carcinoma and Stage II Bladder Urothelial Carcinoma, is actively recruiting participants, sponsored by Alliance for Clinical Trials in Oncology.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 271 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Primary Outcome
Will use Kaplan Meier survival analysis to estimate the proportion of patients who are recurrence-free at three years. Will use a one-sided 90% confidence interval.
Conditions Studied
Interventions
- DRUG Cisplatin
- BIOLOGICAL Pegfilgrastim
- DRUG Gemcitabine Hydrochloride
- PROCEDURE Conventional Surgery
- PROCEDURE Radical Cystectomy
Study Locations (20)
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Mercy Cancer Center - Elk Grove - Elk Grove
- Cedars Sinai Medical Center - Los Angeles
- Contra Costa Regional Medical Center - Martinez
- Fremont - Rideout Cancer Center - Marysville
- Mercy Cancer Center - Merced
- Mercy Cancer Center - Rocklin - Rocklin
- Mercy Cancer Center - Sacramento - Sacramento
- University of California Davis Comprehensive Cancer Center - Sacramento
- Pacific Central Coast Health Center-San Luis Obispo - San Luis Obispo
- Mission Hope Medical Oncology - Santa Maria - Santa Maria
- Saint Joseph's Medical Center - Stockton
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- University of Arkansas for Medical Sciences - Little Rock
Arizona
- CTCA at Western Regional Medical Center - Goodyear
- Cancer Center at Saint Joseph's - Phoenix
Alaska
- Fairbanks Memorial Hospital - Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 271 participants |
| Start Date | 2018-12-10 |
| Est. Completion | 2029-02-01 |
| Phase | Phase 2 |
What NCT03609216 shows while recruiting
NCT03609216 is an interventional study that assigns participants to a tested intervention. The registered 271 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (104% higher).
The record links to 3 conditions, with Infiltrating Bladder Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT03609216 names 20 study sites across 4 states, led by California, Arkansas, Arizona.
Frequently Asked Questions
What is clinical trial NCT03609216 about?
NCT03609216 is a clinical study titled "Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations". This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing...
What is the current status of trial NCT03609216?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 271 participants. The study started on 2018-12-10. Estimated completion is 2029-02-01.
What conditions does trial NCT03609216 study?
This clinical trial studies the following conditions: Infiltrating Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma.
What interventions are being tested in trial NCT03609216?
The interventions under investigation include: Cisplatin (DRUG), Pegfilgrastim (BIOLOGICAL), Gemcitabine Hydrochloride (DRUG), Conventional Surgery (PROCEDURE), Radical Cystectomy (PROCEDURE).
Who is sponsoring clinical trial NCT03609216?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03609216 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03609216's enrollment target sits among peer trials
271 205th of 2000 higher than 1,796 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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