Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Alert icon

This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

  1. Add the dataset to your request by clicking 'Add to Request' button below. You may add dataset(s) with up to 5 clinical trials in a single request.
  2. After adding all desired datasets to your request, you must complete a request form accessible via the 'My Data Requests' link in your account profile. After submitting your data request form, your request will be delivered to NCI for approval.
  3. Once your request is approved, you will receive notice that you have access to the dataset(s) in SAS® Life Sciences Analytic Framework within the Project Data Sphere Cancer Research Platform and that you may download the dataset(s) onto a personal machine.

To be able to request access to this data and the other analytic tools click here.

Uterine

A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) Versus Observation for Uterus-Limited, High-Grade Uterine Leiomyosarcoma

Unique Dataset IDnci-data-405ClinicalTrial.gov IDNCT01533207
DownloadableNo
SponsorGynecologic Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients216RandomizationYesPubMed (PMID)30289732.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeBiologics, Other, DrugDataset TypeOther

Clinical Trial Title

A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) Versus Observation for Uterus-Limited, High-Grade Uterine Leiomyosarcoma

Trial Summary and Conditions

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.

Data Summary

See Data Dictionary.

Study Objectives

Primary: To determine whether overall survival of patients with uterus-limited high-grade leiomyosarcoma is superior among patients assigned to treatment with adjuvant gemcitabine hydrochloride plus docetaxel followed by doxorubicin hydrochloride compared to patients assigned to observation. Secondary: To determine whether treatment with adjuvant gemcitabine plus docetaxel followed by doxorubicin improves recurrence-free survival of patients with uterus-limited high-grade leiomyosarcoma compared to observation; To explore the impact of potential predictors of recurrence or death such as patient age, institution-reported tumor size, cervix involvement (yes or no), and mitotic rate.

Outcome Measures

Primary: Overall survival. Secondary: Incidence of Adverse Events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0; Recurrence-Free Survival.

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

This dataset will allow users to reproduce the treatment comparison between Adjuvant Gemcitabine Plus Docetaxel Followed by Doxorubicin and Observation from PubMed 30289732.

Available Downloads: NCT01533207-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT01533207-D1-Data-Dictionary_1.pdf

DATA: NCT01533207-D1-Dataset_1.csv

OTHER: README.pdf

Available Downloads: NCT01533207-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT01533207-D2-Data-Dictionary_2.pdf

DATA: NCT01533207-D2-Dataset_1.csv

OTHER: README.pdf