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NCT00942331 · ClinicalTrials.gov registry record · Phase 3
Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 506
- Enrollment target
NCT00942331: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00942331 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 506 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00942331, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 506 participants
- Enrollment target
Study Summary
This randomized phase III trial studies gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride and cisplatin in treating patients with urinary tract cancer that has spread to other places in the body. 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. Immunotherapy with bevacizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether gemcitabine hydrochloride and cisplatin are more effective when given with or without bevacizumab in treating patients with urinary tract cancer.
Primary Outcome
Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.The stratified log-rank statistic will be the primary analysis to compare the two treatment arms on OS with the stratification factors: presence of visceral metastases (no, yes) and prior chemotherapy (no, yes). In addition, the proportional hazards model will be used to assess the importance of the treatment arm adjusti
Interventions
- DRUG Cisplatin
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Bevacizumab
- DRUG Gemcitabine Hydrochloride
- OTHER Placebo Administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 506 participants |
| Start Date | 2009-07-15 |
| Est. Completion | 2021-06-15 |
| Phase | Phase 3 |
What the finished NCT00942331 record still lists
NCT00942331 is an interventional study that assigns participants to a tested intervention. The registered 506 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 (34% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT00942331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00942331 about?
NCT00942331 is a clinical study titled "Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer". This randomized phase III trial studies gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride and cisplatin in treating patients with urinary tract cancer that has spread to other places in the body. Drugs used in chemotherapy, such a...
What is the current status of trial NCT00942331?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 506 participants. The study started on 2009-07-15. Estimated completion is 2021-06-15.
What interventions are being tested in trial NCT00942331?
The interventions under investigation include: Cisplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Bevacizumab (BIOLOGICAL), Gemcitabine Hydrochloride (DRUG), Placebo Administration (OTHER).
Who is sponsoring clinical trial NCT00942331?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00942331's enrollment target sits among peer trials
506 741st of 2000 higher than 1,259 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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