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NCT01533207 · ClinicalTrials.gov registry record · Phase 3
Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery
A Phase 3 study, sponsored by Gynecologic Oncology Group.
- Terminated
- Registry status
- Phase 3
- Development phase
- 38
- Enrollment target
NCT01533207: Clinical Trial Phase 3 study, sponsored by Gynecologic Oncology Group.
NCT01533207 is a Phase 3 study that was terminated before completion, run by Gynecologic Oncology Group. The registered enrollment target is 38 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01533207, a Phase 3 study, was terminated before completion, sponsored by Gynecologic Oncology Group.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 38 participants
- Enrollment target
Study Summary
This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, 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. It is not yet known whether combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.
Primary Outcome
The duration of time from study entry to time of death or the date of last contact.
Interventions
- DRUG Docetaxel
- DRUG Doxorubicin Hydrochloride
- BIOLOGICAL Filgrastim
- OTHER Clinical Observation
- DRUG Gemcitabine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-06-04 |
| Est. Completion | 2019-02-09 |
| Phase | Phase 3 |
Why NCT01533207 stopped before completion
NCT01533207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT01533207 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01533207 about?
NCT01533207 is a clinical study titled "Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery". This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydroc...
What is the current status of trial NCT01533207?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2012-06-04. Estimated completion is 2019-02-09.
What interventions are being tested in trial NCT01533207?
The interventions under investigation include: Docetaxel (DRUG), Doxorubicin Hydrochloride (DRUG), Filgrastim (BIOLOGICAL), Clinical Observation (OTHER), Gemcitabine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01533207?
This trial is sponsored by Gynecologic Oncology Group, which has 154 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01533207's enrollment target sits among peer trials
38 1900th of 2000 higher than 100 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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