NCT01958580 · STUDY IN CONTEXT

Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Two-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution. In the event of censoring before two years, a Kaplan-Meier estimate of the survival probability will be used and a Kaplan-Meier survival curve will be estimated and presented as well. The study was terminated prior to analyses

Data pertaining to Recurrence-free Survival was not collected/aggregated and therefore not analyzed.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-leiomyosarcoma
nct id: NCT01958580
trial label: Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 1
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01958580
outcome key
om-0000
source section id
NCT01958580-om-0000
source outcome index
0
endpoint
Recurrence-free Survival
endpoint definition
Two-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution. In the event of censoring before two years, a Kaplan-Meier estimate of the survival probability will be used and a Kaplan-Meier survival curve will be estimated and presented as well. The study was terminated prior to analyses
time origin
Date of entry to date of reappearance of disease, assessed at 2 years. The study was terminated prior to analyses
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Data pertaining to Recurrence-free Survival was not collected/aggregated and therefore not analyzed.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01958580
outcome key
om-0000
arm key
OG000
arm label
Treatment (Gemcitabine, Docetaxel, Brachytherapy/IMRT, EBRT)
regimen
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks. Gemcitabine Hydrochloride: Given IV Docetaxel: Given IV Internal Radiation Therapy: Undergo brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT External Beam Radiation Therapy: Undergo EBRT Laboratory Biomarker Analysis: Correlative studies
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01958580-om-0000#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01958580
harm key
EG000
source section id
NCT01958580-ae
event group key
EG000
event group label
Treatment (Gemcitabine, Docetaxel, Brachytherapy/IMRT, EBRT)
serious affected
1
serious at risk
3
other affected
1
other at risk
3
frequency threshold
0
collection period
Up to 1 year following completion of treatment (~69 weeks total)
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice