TriangleNCT00282087 · STUDY IN CONTEXT
Adjuvant Chemotherapy for High Risk 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
Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.
Correlation Between Age and Tumor Response to Treatment (PFS)
Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)
AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only
Mitotic rate is measured in mitoses per 10 high-power fields
Reported safety
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
- NCT00282087
- trial label
- Adjuvant Chemotherapy for High Risk 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
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT00282087
- outcome key
- om-0000
- source section id
- NCT00282087-om-0000
- source outcome index
- 0
- endpoint
- Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
- endpoint definition
- Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
- time origin
- Every 3 months up to two 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT00282087
- outcome key
- om-0001
- source section id
- NCT00282087-om-0001
- source outcome index
- 1
- endpoint
- Tolerability/Toxicity of This Regimen
- endpoint definition
- Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.
- time origin
- Every 28 days during dosing and then every 3 months thereafter until patient comes off study
- analysis role
- secondary
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT00282087
- outcome key
- om-0002
- source section id
- NCT00282087-om-0002
- source outcome index
- 2
- endpoint
- Correlation Between Age and Tumor Response to Treatment (PFS)
- endpoint definition
- Correlation Between Age and Tumor Response to Treatment (PFS)
- time origin
- 2 years
- analysis role
- secondary
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT00282087
- outcome key
- om-0003
- source section id
- NCT00282087-om-0003
- source outcome index
- 3
- endpoint
- Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)
- endpoint definition
- Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)
- time origin
- 2 years
- analysis role
- secondary
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT00282087
- outcome key
- om-0004
- source section id
- NCT00282087-om-0004
- source outcome index
- 4
- endpoint
- Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)
- endpoint definition
- AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only
- time origin
- 2 years
- analysis role
- secondary
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT00282087
- outcome key
- om-0005
- source section id
- NCT00282087-om-0005
- source outcome index
- 5
- endpoint
- Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)
- endpoint definition
- Mitotic rate is measured in mitoses per 10 high-power fields
- time origin
- 2 years
- analysis role
- secondary
- 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT00282087
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Women Treated With Adjuvant Regimen for High Risk Uterine LMS
- regimen
- Women Treated With Adjuvant Regimen for High Risk Uterine LMS
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00282087-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT00282087
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Women Treated With Adjuvant Regimen for High Risk Uterine LMS
- regimen
- Number of major toxicity events
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00282087-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT00282087
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Women Treated With Adjuvant Regimen for High Risk Uterine LMS
- regimen
- Women Treated With Adjuvant Regimen for High Risk Uterine LMS
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00282087-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT00282087
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Women Treated With Adjuvant Regimen for High Risk Uterine LMS
- regimen
- Women Treated With Adjuvant Regimen for High Risk Uterine LMS
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00282087-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT00282087
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Women Treated With Adjuvant Regimen for High Risk Uterine LMS
- regimen
- Women Treated With Adjuvant Regimen for High Risk Uterine LMS
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00282087-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT00282087
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Women Treated With Adjuvant Regimen for High Risk Uterine LMS
- regimen
- Women Treated With Adjuvant Regimen for High Risk Uterine LMS
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00282087-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT00282087
- harm key
- EG000
- source section id
- NCT00282087-ae
- event group key
- EG000
- event group label
- Women Treated With Adjuvant Regimen for High Risk Uterine LMS
- serious affected
- 9
- serious at risk
- 47
- other affected
- 14
- other at risk
- 47
- frequency threshold
- 4
- 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