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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 is a Phase 3 study that was terminated before completion, run by Gynecologic Oncology Group. The registered enrollment target is 38 participants.

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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.

Interventions

  • DRUG Docetaxel
  • DRUG Doxorubicin Hydrochloride
  • BIOLOGICAL Filgrastim
  • OTHER Clinical Observation
  • DRUG Gemcitabine Hydrochloride

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2012-06-04
Est. Completion 2019-02-09
Phase Phase 3

Sponsor

Gynecologic Oncology Group

154 total trials

What the Registry Record Tells You About NCT01533207

The ClinicalTrials.gov registry entry for NCT01533207 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gynecologic Oncology Group, which has 154 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.

NCT01533207 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.