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NCT00257816 · ClinicalTrials.gov registry record · Phase 2
Weekly IV Topotecan and Cisplatin With Radiation in Cervical Carcinoma
A Phase 2 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00257816: Completed Phase 2 study, sponsored by University of California, Irvine.
NCT00257816 is a Phase 2 study that has completed, run by University of California, Irvine. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00257816, a Phase 2 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
There will be approximately 14,000 new patients with invasive cervical cancer diagnosed in the United States in 2003 with about 4,000 deaths from this disease. This accounts for approximately 17% of all deaths due to gynecologic cancers. Radiation has been the primary treatment modality for locoregionally advanced cervical cancer. Recent trials of concomitant systemic cisplatin chemotherapy and radiation have shown high response rates (RR) with improvements in durable remissions and overall survival. Though the incidence and mortality in the U.S. dropped steadily from years 1940 to 2000, there has recently been a plateau, arresting the decline. With the routine addition of systemic Cisplatin (CDDP) chemotherapy to local regional radiation, mortality from advanced cervical cancer in the United States is expected to further decrease. However, further advances in this disease are needed.
Primary Outcome
Topotecan improves response rate (RR), progression-free survival (PFS) and overall survival (OS) when added to cisplatin in treating metastatic and recurrent cervical cancer. The objective of this study was to assess the feasibility of adding weekly topotecan to cisplatin in patients with primary, locally advanced carcinoma of the cervix receiving pelvic irradiation.
Interventions
- DRUG Cisplatin
- DRUG Topotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2004-01 |
| Est. Completion | 2007-12-17 |
| Phase | Phase 2 |
What the finished NCT00257816 record still lists
NCT00257816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Cisplatin is the first listed.
NCT00257816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00257816 about?
NCT00257816 is a clinical study titled "Weekly IV Topotecan and Cisplatin With Radiation in Cervical Carcinoma". There will be approximately 14,000 new patients with invasive cervical cancer diagnosed in the United States in 2003 with about 4,000 deaths from this disease. This accounts for approximately 17% of all deaths due to gynecologic cancers. Radiation has been the primary treatment modality for locoregi...
What is the current status of trial NCT00257816?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2004-01. Estimated completion is 2007-12-17.
What interventions are being tested in trial NCT00257816?
The interventions under investigation include: Cisplatin (DRUG), Topotecan (DRUG).
Who is sponsoring clinical trial NCT00257816?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00257816's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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