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← Mixed Mesodermal (Mullerian) Tumor

NCT00954174 · STUDY IN CONTEXT

Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer

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

Measured in months from randomization to last contact or death. Primary analysis was restricted to the eligible uterine carcinosarcoma cohort.

All eligible patients

→

secondary · POSTED

Measured in months from randomization to last contact or the earlier of the date of progression or death.

All eligible patients

→

secondary · POSTED

Maximum grade experienced among all treated and eligible patients. The grades are described by severity. Grade 1 is the lowest (most mild) and Grade 5 being death (most severe). Adverse events were analyzed across cohorts since disease site was considered independent of AEs.

Treated and Eligible subjects. Adverse events were analyzed across cohorts since disease site was considered independent of AEs.

→

secondary · POSTED

Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.

Patients who provided baseline assessments.

→

secondary · POSTED

Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.

Provided baseline and ≥ 1 follow-up assessments

→

secondary · POSTED

Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.

Subjects who provided baseline assessment

→

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 · Patient-Reported Quality of Life (QOL) - Baseline

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-mixed-mesodermal-mullerian-tumor
nct id
NCT00954174
qol key
qol-0003
source section id
NCT00954174-om-0003
source outcome index
3
instrument
FACT
instrument basis
matched 'fact-en' in the study's own wording
scale title
Patient-Reported Quality of Life (QOL) - Baseline
measure definition
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
time frame
Baseline - Prior to study treatment
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Patients who provided baseline assessments.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Patient Reported Quality of Life (QOL) - Post Baseline

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-mixed-mesodermal-mullerian-tumor
nct id
NCT00954174
qol key
qol-0004
source section id
NCT00954174-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'fact-en' in the study's own wording
scale title
Patient Reported Quality of Life (QOL) - Post Baseline
measure definition
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
time frame
Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Provided baseline and ≥ 1 follow-up assessments
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Patient Reported Peripheral Neuropathy Symptoms - Baseline

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-mixed-mesodermal-mullerian-tumor
nct id
NCT00954174
qol key
qol-0005
source section id
NCT00954174-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Patient Reported Peripheral Neuropathy Symptoms - Baseline
measure definition
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
time frame
Baseline (Pre cycle 1)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Subjects who provided baseline assessment
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Patient-reported Peripheral Neuropathy Symptoms - Post Baseline

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-mixed-mesodermal-mullerian-tumor
nct id
NCT00954174
qol key
qol-0006
source section id
NCT00954174-om-0006
source outcome index
6
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Patient-reported Peripheral Neuropathy Symptoms - Post Baseline
measure definition
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms.Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
time frame
Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Provided baseline and ≥ 1 follow-up assessments
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-mixed-mesodermal-mullerian-tumor
nct id
NCT00954174
trial label
Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer
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
2
qol Count
4
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0000
    source section id
    NCT00954174-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    Measured in months from randomization to last contact or death. Primary analysis was restricted to the eligible uterine carcinosarcoma cohort.
    time origin
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 115 months.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible patients
    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-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0001
    source section id
    NCT00954174-om-0001
    source outcome index
    1
    endpoint
    Duration of Progression-free Survival
    endpoint definition
    Measured in months from randomization to last contact or the earlier of the date of progression or death.
    time origin
    Approximately 9 years and 7 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible patients
    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-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0002
    source section id
    NCT00954174-om-0002
    source outcome index
    2
    endpoint
    Incidence of Adverse Events as Assessed by CTCAE Version 3.0
    endpoint definition
    Maximum grade experienced among all treated and eligible patients. The grades are described by severity. Grade 1 is the lowest (most mild) and Grade 5 being death (most severe). Adverse events were analyzed across cohorts since disease site was considered independent of AEs.
    time origin
    Patients were assessed for adverse events during active protocol treatment and up to 30 days after the last cycle of treatment on the protocol.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Treated and Eligible subjects. Adverse events were analyzed across cohorts since disease site was considered independent of AEs.
    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-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0003
    source section id
    NCT00954174-om-0003
    source outcome index
    3
    endpoint
    Patient-Reported Quality of Life (QOL) - Baseline
    endpoint definition
    Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
    time origin
    Baseline - Prior to study treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who provided baseline assessments.
    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-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0004
    source section id
    NCT00954174-om-0004
    source outcome index
    4
    endpoint
    Patient Reported Quality of Life (QOL) - Post Baseline
    endpoint definition
    Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
    time origin
    Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Provided baseline and ≥ 1 follow-up assessments
    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-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0005
    source section id
    NCT00954174-om-0005
    source outcome index
    5
    endpoint
    Patient Reported Peripheral Neuropathy Symptoms - Baseline
    endpoint definition
    Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
    time origin
    Baseline (Pre cycle 1)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Subjects who provided baseline assessment
    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-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Regimen I- Uterine Carcinsarcoma Subjects
    regimen
    Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
    analyzed count
    228
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00954174-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Regimen II - Uterine Carcinsarcoma Subjects
    regimen
    Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
    analyzed count
    221
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00954174-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Regimen I - Uterine Carcinsarcoma Subjects
    regimen
    Paclitaxel 175 mg/m2 IV over 3 hours Day 1. Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
    analyzed count
    228
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00954174-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Regimen II - Uterine Carcinsarcoma Subjects
    regimen
    Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
    analyzed count
    221
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00954174-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Regimen III - Non-uterine Carcinsarcoma Subjects
    regimen
    Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
    analyzed count
    44
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00954174-om-0001#groups/OG002
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0001
    arm key
    OG003
    arm label
    Regimen IV - Non-uterine Carcinsarcoma Subjects
    regimen
    Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
    analyzed count
    46
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00954174-om-0001#groups/OG003
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Regimen I - Uterine and Non-Uterine Subjects
    regimen
    Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
    analyzed count
    268
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00954174-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Regimen II - All Uterine and Non-Uterine Subjects
    regimen
    Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
    analyzed count
    247
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00954174-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Regimen I - Uterine and Non-Uterine Subjects
    regimen
    Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1. Carboplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
    analyzed count
    205
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00954174-om-0003#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Regimen II - Uterine and Non-Uterine Subjects
    regimen
    Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I. Ifosfamide: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
    analyzed count
    184
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00954174-om-0003#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Regimen I - Uterine and Non-Uterine Subjects
    regimen
    Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1. Carboplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
    analyzed count
    205
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00954174-om-0004#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Regimen II - Uterine and Non-Uterine Subjects
    regimen
    Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I. Ifosfamide: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
    analyzed count
    184
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00954174-om-0004#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    harm key
    EG000
    source section id
    NCT00954174-ae
    event group key
    EG000
    event group label
    Regimen I - Uterine and Non-uterine Carcinosarcoma
    serious affected
    80
    serious at risk
    268
    other affected
    268
    other at risk
    268
    frequency threshold
    0
    collection period
    Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.
    event definition
    Eligible and treated participants were affected if they experienced grade 1-5 adverse event. Adverse events were analyzed across cohorts since disease site was considered independent of AEs.
    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-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    harm key
    EG001
    source section id
    NCT00954174-ae
    event group key
    EG001
    event group label
    Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects
    serious affected
    68
    serious at risk
    247
    other affected
    244
    other at risk
    247
    frequency threshold
    0
    collection period
    Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.
    event definition
    Eligible and treated participants were affected if they experienced grade 1-5 adverse event. Adverse events were analyzed across cohorts since disease site was considered independent of AEs.
    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-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    qol key
    qol-0003
    source section id
    NCT00954174-om-0003
    source outcome index
    3
    instrument
    FACT
    instrument basis
    matched 'fact-en' in the study's own wording
    scale title
    Patient-Reported Quality of Life (QOL) - Baseline
    measure definition
    Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
    time frame
    Baseline - Prior to study treatment
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Patients who provided baseline assessments.
    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-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    qol key
    qol-0004
    source section id
    NCT00954174-om-0004
    source outcome index
    4
    instrument
    FACT
    instrument basis
    matched 'fact-en' in the study's own wording
    scale title
    Patient Reported Quality of Life (QOL) - Post Baseline
    measure definition
    Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
    time frame
    Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Provided baseline and ≥ 1 follow-up assessments
    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-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    qol key
    qol-0005
    source section id
    NCT00954174-om-0005
    source outcome index
    5
    instrument
    FACT
    instrument basis
    matched 'fact' in the study's own wording
    scale title
    Patient Reported Peripheral Neuropathy Symptoms - Baseline
    measure definition
    Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
    time frame
    Baseline (Pre cycle 1)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Subjects who provided baseline assessment
    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-mixed-mesodermal-mullerian-tumor
    nct id
    NCT00954174
    qol key
    qol-0006
    source section id
    NCT00954174-om-0006
    source outcome index
    6
    instrument
    FACT
    instrument basis
    matched 'fact' in the study's own wording
    scale title
    Patient-reported Peripheral Neuropathy Symptoms - Post Baseline
    measure definition
    Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms.Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
    time frame
    Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Provided baseline and ≥ 1 follow-up assessments
    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