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← Leiomyosarcoma

NCT01533207 · STUDY IN CONTEXT

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

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.

exploratory · NOT_POSTED

Analyses will be carried out using proportional hazards models of both survival and recurrence.

Source null

→

primary · POSTED

The duration of time from study entry to time of death or the date of last contact.

Eligible and evaluable participants

→

secondary · POSTED

Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

eligible and randomized patients

→

secondary · POSTED

The duration of time from study entry to time of recurrence or death, whichever occurred first, or the date of last contact.

Eligible and evaluable participants

→

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

FACT · Univariate and Multi-variable Prognostic Significance of Baseline Clinical, Pathologic, or Demographic Factors

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01533207
qol key
qol-0003
source section id
NCT01533207-om-0003
source outcome index
3
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Univariate and Multi-variable Prognostic Significance of Baseline Clinical, Pathologic, or Demographic Factors
measure definition
Analyses will be carried out using proportional hazards models of both survival and recurrence.
time frame
Up to 5 years
analysis role
exploratory
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01533207
trial label
Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surger
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
4
harms Count
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-leiomyosarcoma
    nct id
    NCT01533207
    outcome key
    om-0003
    source section id
    NCT01533207-om-0003
    source outcome index
    3
    endpoint
    Univariate and Multi-variable Prognostic Significance of Baseline Clinical, Pathologic, or Demographic Factors
    endpoint definition
    Analyses will be carried out using proportional hazards models of both survival and recurrence.
    time origin
    Up to 5 years
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-leiomyosarcoma
    nct id
    NCT01533207
    outcome key
    om-0000
    source section id
    NCT01533207-om-0000
    source outcome index
    0
    endpoint
    Number of Participants Who Experienced Death
    endpoint definition
    The duration of time from study entry to time of death or the date of last contact.
    time origin
    Follow-up every 4 months for 3 years, then every 6 months for 2 years.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and evaluable participants
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-leiomyosarcoma
    nct id
    NCT01533207
    outcome key
    om-0001
    source section id
    NCT01533207-om-0001
    source outcome index
    1
    endpoint
    Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
    endpoint definition
    Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
    time origin
    Approximately 4 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    eligible and randomized patients
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-leiomyosarcoma
    nct id
    NCT01533207
    outcome key
    om-0002
    source section id
    NCT01533207-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With Recurrence
    endpoint definition
    The duration of time from study entry to time of recurrence or death, whichever occurred first, or the date of last contact.
    time origin
    Follow-up every 4 months for 3 years, then every 6 months for 2 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and evaluable participants
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-leiomyosarcoma
    nct id
    NCT01533207
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Regimen 1
    regimen
    Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01533207-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-leiomyosarcoma
    nct id
    NCT01533207
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Regimen II
    regimen
    Observation
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01533207-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-leiomyosarcoma
    nct id
    NCT01533207
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Regimen 1
    regimen
    Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01533207-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-leiomyosarcoma
    nct id
    NCT01533207
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Regimen II
    regimen
    Observation
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01533207-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-leiomyosarcoma
    nct id
    NCT01533207
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Regimen 1
    regimen
    Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01533207-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-leiomyosarcoma
    nct id
    NCT01533207
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Regimen II
    regimen
    Observation
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01533207-om-0002#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-leiomyosarcoma
    nct id
    NCT01533207
    harm key
    EG000
    source section id
    NCT01533207-ae
    event group key
    EG000
    event group label
    Regimen 1
    serious affected
    5
    serious at risk
    20
    other affected
    16
    other at risk
    20
    frequency threshold
    0
    collection period
    For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-leiomyosarcoma
    nct id
    NCT01533207
    harm key
    EG001
    source section id
    NCT01533207-ae
    event group key
    EG001
    event group label
    Regimen II
    serious affected
    0
    serious at risk
    18
    other affected
    12
    other at risk
    18
    frequency threshold
    0
    collection period
    For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-leiomyosarcoma
    nct id
    NCT01533207
    qol key
    qol-0003
    source section id
    NCT01533207-om-0003
    source outcome index
    3
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    Univariate and Multi-variable Prognostic Significance of Baseline Clinical, Pathologic, or Demographic Factors
    measure definition
    Analyses will be carried out using proportional hazards models of both survival and recurrence.
    time frame
    Up to 5 years
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice