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← Uterine Sarcoma

NCT01061606 · STUDY IN CONTEXT

Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus

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

Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST

Source null

→

primary · POSTED

The 6-month progression-free rate is defined as the total number of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of efficacy-evaluable patients enrolled on study.

The study concluded terminated early and patients were not followed.

→

secondary · POSTED

Time to event distributions will be estimated using the Kaplan-Meier method.

The study concluded terminated early and patients were not followed.

→

secondary · POSTED

Median duration of response and the confidence interval for the median duration will be computed.

The study concluded terminated early and patients were not followed.

→

secondary · POSTED

Time to treatment failure will be evaluated using the method of Kaplan-Meier.

The study concluded terminated early and patients were not followed.

→

secondary · POSTED

Time to Progression

The study concluded terminated early and patients were not followed.

→

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-sarcoma
nct id
NCT01061606
trial label
Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus
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
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma
    nct id
    NCT01061606
    outcome key
    om-0000
    source section id
    NCT01061606-om-0000
    source outcome index
    0
    endpoint
    Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST
    endpoint definition
    Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST
    time origin
    Up to 3 years
    analysis role
    primary
    reporting status
    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-uterine-sarcoma
    nct id
    NCT01061606
    outcome key
    om-0001
    source section id
    NCT01061606-om-0001
    source outcome index
    1
    endpoint
    Progression Free Survival
    endpoint definition
    The 6-month progression-free rate is defined as the total number of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of efficacy-evaluable patients enrolled on study.
    time origin
    6 months from registration
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study concluded terminated early and patients were not followed.
    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-uterine-sarcoma
    nct id
    NCT01061606
    outcome key
    om-0002
    source section id
    NCT01061606-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Time to event distributions will be estimated using the Kaplan-Meier method.
    time origin
    From registration to death, assessed up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study concluded terminated early and patients were not followed.
    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-uterine-sarcoma
    nct id
    NCT01061606
    outcome key
    om-0003
    source section id
    NCT01061606-om-0003
    source outcome index
    3
    endpoint
    Duration of Response, Defined for All Evaluable Patients Who Have Achieved an Objective Response as the Date at Which the Patient's Objective Status is First Noted to be Either a CR or PR to the Date Progression is Documented
    endpoint definition
    Median duration of response and the confidence interval for the median duration will be computed.
    time origin
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study concluded terminated early and patients were not followed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma
    nct id
    NCT01061606
    outcome key
    om-0004
    source section id
    NCT01061606-om-0004
    source outcome index
    4
    endpoint
    Time to Treatment Failure
    endpoint definition
    Time to treatment failure will be evaluated using the method of Kaplan-Meier.
    time origin
    From study registration to the date patients end treatment, assessed up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study concluded terminated early and patients were not followed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma
    nct id
    NCT01061606
    outcome key
    om-0005
    source section id
    NCT01061606-om-0005
    source outcome index
    5
    endpoint
    Time to Progression
    endpoint definition
    Time to Progression
    time origin
    Time to progression is defined as the time from registration to disease progression.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The study concluded terminated early and patients were not followed.
    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-sarcoma
    nct id
    NCT01061606
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Temsirolimus)
    regimen
    Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. temsirolimus: Given IV
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01061606-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma
    nct id
    NCT01061606
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Temsirolimus)
    regimen
    Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. temsirolimus: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01061606-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma
    nct id
    NCT01061606
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Temsirolimus)
    regimen
    Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. temsirolimus: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01061606-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma
    nct id
    NCT01061606
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Temsirolimus)
    regimen
    Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. temsirolimus: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01061606-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma
    nct id
    NCT01061606
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment (Temsirolimus)
    regimen
    Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. temsirolimus: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01061606-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma
    nct id
    NCT01061606
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment (Temsirolimus)
    regimen
    Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. temsirolimus: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01061606-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma
    nct id
    NCT01061606
    harm key
    EG000
    source section id
    NCT01061606-ae
    event group key
    EG000
    event group label
    Treatment (Temsirolimus)
    serious affected
    5
    serious at risk
    8
    other affected
    8
    other at risk
    8
    frequency threshold
    5
    collection period
    Source null
    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