Trial · NCT01533207

Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery

NCT01533207, Phase 3, Terminated, Gynecologic Oncology Group; results first posted 2020-04-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery. Trials, record NCT01533207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01533207

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery
NCT number: NCT01533207
Status: Terminated
Phases: Phase 3
Enrollment: 38 participants, actual
Lead sponsor: Gynecologic Oncology Group
Conditions: Stage I Uterine Sarcoma AJCC v7, Uterine Corpus Leiomyosarcoma
Interventions: Clinical Observation, Docetaxel, Doxorubicin Hydrochloride, Filgrastim, Gemcitabine Hydrochloride, Pegfilgrastim
First posted: 2012-02-15
Last updated: 2020-04-28
Results first posted: 2020-04-06
Limitations and caveats: The study was closed early due to slow participant accrual.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants Who Experienced Death	Follow-up every 4 months for 3 years, then every 6 months for 2 years.	The duration of time from study entry to time of death or the date of last contact.
Secondary	Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0	Approximately 4 years
Secondary	Number of Participants With Recurrence	Follow-up every 4 months for 3 years, then every 6 months for 2 years.	The duration of time from study entry to time of recurrence or death, whichever occurred first, or the date of last contact.
Other	Univariate and Multi-variable Prognostic Significance of Baseline Clinical, Pathologic, or Demographic Factors	Up to 5 years	Analyses will be carried out using proportional hazards models of both survival and recurrence.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Who Experienced Death	Follow-up every 4 months for 3 years, then every 6 months for 2 years.	Eligible and evaluable participants	Participants	NUMBER
SECONDARY	Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0	Approximately 4 years	eligible and randomized patients	participants	NUMBER
SECONDARY	Number of Participants With Recurrence	Follow-up every 4 months for 3 years, then every 6 months for 2 years.	Eligible and evaluable participants	participants	NUMBER
OTHER_PRE_SPECIFIED	Univariate and Multi-variable Prognostic Significance of Baseline Clinical, Pathologic, or Demographic Factors	Up to 5 years

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants Who Experienced Death	Regimen 1	5	Participants
Number of Participants Who Experienced Death	Regimen II	1	Participants
Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0	Regimen 1	10	participants
Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0	Regimen II	1	participants
Number of Participants With Recurrence	Regimen 1	8	participants
Number of Participants With Recurrence	Regimen II	8	participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Regimen 1	20
Overall Study	STARTED	Regimen II	18
Overall Study	COMPLETED	Regimen 1	20
Overall Study	COMPLETED	Regimen II	18
Overall Study	NOT COMPLETED	Regimen 1	0
Overall Study	NOT COMPLETED	Regimen II	0

Source ClinicalTrials.gov

Adverse events248

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Leukocytosis	Blood and lymphatic system disorders	Regimen 1	1	20
other	Leukocytosis	Blood and lymphatic system disorders	Regimen II	0	18
other	Blood And Lymphatic System Disorders - Other	Blood and lymphatic system disorders	Regimen 1	3	20
other	Blood And Lymphatic System Disorders - Other	Blood and lymphatic system disorders	Regimen II	0	18
other	Anemia	Blood and lymphatic system disorders	Regimen 1	13	20
other	Anemia	Blood and lymphatic system disorders	Regimen II	1	18
other	Atrial Fibrillation	Cardiac disorders	Regimen 1	1	20
other	Atrial Fibrillation	Cardiac disorders	Regimen II	0	18
other	Palpitations	Cardiac disorders	Regimen 1	4	20
other	Palpitations	Cardiac disorders	Regimen II	1	18

1 to 10 of 248Source ClinicalTrials.gov

See all 248 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Regimen 1	5	20
Total, all-cause mortality	Regimen II	1	18
Total, other adverse events	Regimen 1	16	20
Total, other adverse events	Regimen II	12	18
Total, serious adverse events	Regimen 1	5	20
Total, serious adverse events	Regimen II	0	18

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180868	NRG Oncology Network Group Operations Center	WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S.	NRG ONCOLOGY FOUNDATION, INC.	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA027469	Gynecologic Oncology Group	DISAIA, PHILIP J.	GYNECOLOGIC ONCOLOGY GROUP	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Regimen 1 vs Regimen II: Number of Participants Who Experienced Death	Trial comparisons
Regimen 1 vs Regimen II: Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0	Trial comparisons
Regimen 1 vs Regimen II: deaths from any cause	Trial comparisons
Regimen 1 vs Regimen II: Number of Participants With Recurrence	Trial comparisons
Regimen 1 vs Regimen II: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01533207

GET https://conductscience.org/api/trials/v1/NCT01533207/events?page=2

API reference For AI assistants