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← Uterine Neoplasm

NCT00414076 · STUDY IN CONTEXT

Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma

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. 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

Number of participants progressed or death from study entry.

1 out of 4 participants in the Letrozole arm progressed on study. 2 participants progressed in standard of care

→

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-uterine-neoplasm
nct id
NCT00414076
trial label
Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma
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.
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
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-neoplasm
    nct id
    NCT00414076
    outcome key
    om-0000
    source section id
    NCT00414076-om-0000
    source outcome index
    0
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    Number of participants progressed or death from study entry.
    time origin
    Every 12 weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    1 out of 4 participants in the Letrozole arm progressed on study. 2 participants progressed in standard of care
    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-uterine-neoplasm
    nct id
    NCT00414076
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Letrozole
    regimen
    Letrozole 2.5 mg Tablet By Mouth Daily for 12 Weeks. Letrozole: 2.5 mg Tablet By Mouth Daily for 12 Weeks.
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00414076-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-neoplasm
    nct id
    NCT00414076
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Standard of Care
    regimen
    Patients receive no treatment. Follow up every 3 months.
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00414076-om-0000#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-neoplasm
    nct id
    NCT00414076
    harm key
    EG000
    source section id
    NCT00414076-ae
    event group key
    EG000
    event group label
    Letrozole
    serious affected
    0
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    0
    collection period
    From study entry to time of progression or death
    event definition
    5 Participants was under observation and received no treatments
    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-uterine-neoplasm
    nct id
    NCT00414076
    harm key
    EG001
    source section id
    NCT00414076-ae
    event group key
    EG001
    event group label
    Standard of Care
    serious affected
    0
    serious at risk
    5
    other affected
    0
    other at risk
    5
    frequency threshold
    0
    collection period
    From study entry to time of progression or death
    event definition
    5 Participants was under observation and received no treatments
    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