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NCT00045630 · ClinicalTrials.gov registry record · Phase 2
S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
A Phase 2 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
NCT00045630: Completed Phase 2 study, sponsored by SWOG Cancer Research Network.
NCT00045630 is a Phase 2 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 77 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00045630, a Phase 2 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and decrease the need for surgery. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by observation or surgery to remove the bladder (cystectomy) in treating patients who have stage II or stage III cancer of the urothelium.
Primary Outcome
Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic d
Interventions
- DRUG carboplatin
- DRUG paclitaxel
- DRUG gemcitabine
- PROCEDURE surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2003-01 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
What the finished NCT00045630 record still lists
NCT00045630 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 4 interventions - of which carboplatin is the first listed.
NCT00045630 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00045630 about?
NCT00045630 is a clinical study titled "S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and decrease the need for surgery. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed b...
What is the current status of trial NCT00045630?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2003-01. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00045630?
The interventions under investigation include: carboplatin (DRUG), paclitaxel (DRUG), gemcitabine (DRUG), surgery (PROCEDURE).
Who is sponsoring clinical trial NCT00045630?
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 NCT00045630's enrollment target sits among peer trials
77 891st of 2000 higher than 1,108 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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