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NCT00445601 · ClinicalTrials.gov registry record · Phase 3
S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
A Phase 3 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 406
- Enrollment target
NCT00445601: Completed Phase 3 study, sponsored by SWOG Cancer Research Network.
NCT00445601 is a Phase 3 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 406 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00445601, a Phase 3 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 406 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine directly into the bladder after surgery may kill more tumor cells. It is not yet known whether giving gemcitabine directly into the bladder is more effective than a placebo in treating bladder cancer. PURPOSE: This randomized phase III trial is studying gemcitabine to see how well it works when given directly into the bladder compared with a placebo after surgery in treating patients with newly diagnosed or recurrent bladder cancer.
Primary Outcome
Percentage of patients who experienced a recurrence of grade 1 or 2 superficial transitional cell cancer of the bladder between the date of registration and 24 months. Disease recurrence considered to occur at date of first observation of recurrent disease subsequently confirmed by biopsy. Patients without recurrence were censored at the time of their last cystoscopy.
Interventions
- OTHER placebo
- DRUG gemcitabine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2007-09 |
| Est. Completion | 2017-06 |
| Phase | Phase 3 |
What the finished NCT00445601 record still lists
NCT00445601 is an interventional study that assigns participants to a tested intervention. The registered 406 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 (47% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00445601 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00445601 about?
NCT00445601 is a clinical study titled "S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer". RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine directly into the bladder after surgery may kill more tumor cells. It is not yet known whether givin...
What is the current status of trial NCT00445601?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 406 participants. The study started on 2007-09. Estimated completion is 2017-06.
What interventions are being tested in trial NCT00445601?
The interventions under investigation include: placebo (OTHER), gemcitabine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00445601?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00445601's enrollment target sits among peer trials
406 913th of 2000 higher than 1,087 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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