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NCT00005047 · ClinicalTrials.gov registry record · Phase 3
4B951, Combination Chemotherapy in Treating Patients With Bladder Cancer
A Phase 3 study, sponsored by SWOG Cancer Research Network.
- Terminated
- Registry status
- Phase 3
- Development phase
- 521
- Enrollment target
NCT00005047: Clinical Trial Phase 3 study, sponsored by SWOG Cancer Research Network.
NCT00005047 is a Phase 3 study that was terminated before completion, run by SWOG Cancer Research Network. The registered enrollment target is 521 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005047, a Phase 3 study, was terminated before completion, sponsored by SWOG Cancer Research Network.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 521 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. It is not yet known whether combination chemotherapy is more effective than observation alone in treating bladder cancer. PURPOSE: This randomized phase III trial is studying combination chemotherapy to see how well it works compared to observation alone in treating patients with bladder cancer.
Primary Outcome
p53 positive patients randomized to MVAC (arm I) compared to p53 positive patients randomized to observation (arm II). Time from registration to the first observation of disease recurrence, censoring patients who died of unrelated causes. Probabilities of recurring were based on cumulative incidence curves. Recurrence is defined as first radiological appearance of bladder cancer, per local standard of care.
Interventions
- DRUG cisplatin
- DRUG methotrexate
- DRUG vinblastine
- DRUG doxorubicin hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 521 participants |
| Start Date | 1997-08 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
Why NCT00005047 stopped before completion
NCT00005047 is an interventional study that assigns participants to a tested intervention. The registered 521 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 (33% lower).
The record links to 0 conditions, and to 4 interventions - of which cisplatin is the first listed.
NCT00005047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005047 about?
NCT00005047 is a clinical study titled "4B951, Combination Chemotherapy in Treating Patients With Bladder Cancer". 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. It is not yet known whether combination chemotherapy is more effective than observation alone in treating bladder cancer. P...
What is the current status of trial NCT00005047?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 521 participants. The study started on 1997-08. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00005047?
The interventions under investigation include: cisplatin (DRUG), methotrexate (DRUG), vinblastine (DRUG), doxorubicin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00005047?
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 NCT00005047's enrollment target sits among peer trials
521 717th of 2000 higher than 1,284 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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