TriangleNCT01012297 · STUDY IN CONTEXT
Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent 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. 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
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group.
Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last followup were censored on the date of last CT Scan. The product-limit method will be used to estimate the cumulative distribution of overall survival times for the patients assigned to each treatment group.
Count of participants with Adverse events (AEs) that are CTCAE Grade 3 or worse. Please refer to the adverse event reporting for more detail.
"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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
- NCT01012297
- trial label
- Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent 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. 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
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01012297
- outcome key
- om-0000
- source section id
- NCT01012297-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival
- endpoint definition
- Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group.
- 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 60 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized
- 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
- NCT01012297
- outcome key
- om-0001
- source section id
- NCT01012297-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival
- endpoint definition
- Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last followup were censored on the date of last CT Scan. The product-limit method will be used to estimate the cumulative distribution of overall survival times for the patients assigned to each treatment group.
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized
- 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
- NCT01012297
- outcome key
- om-0002
- source section id
- NCT01012297-om-0002
- source outcome index
- 2
- endpoint
- Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0
- endpoint definition
- Count of participants with Adverse events (AEs) that are CTCAE Grade 3 or worse. Please refer to the adverse event reporting for more detail.
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized.
- 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
- NCT01012297
- outcome key
- om-0003
- source section id
- NCT01012297-om-0003
- source outcome index
- 3
- endpoint
- Objective Response Rate as Measured by RECIST 1.1 Criteria
- endpoint definition
- "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized
- 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
- NCT01012297
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I Gem+Doce+Placebo
- regimen
- Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC Placebo: Given IV
- analyzed count
- 54
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01012297-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01012297
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II Gem+Doce+Bev
- regimen
- Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10. Bevacizumab: Given IV Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC
- analyzed count
- 53
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01012297-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01012297
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I Gem+Doce+Placebo
- regimen
- Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC Placebo: Given IV
- analyzed count
- 54
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01012297-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01012297
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II Gem+Doce+Bev
- regimen
- Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10. Bevacizumab: Given IV Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC
- analyzed count
- 53
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01012297-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01012297
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I Gem+Doce+Placebo
- regimen
- Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC Placebo: Given IV
- analyzed count
- 54
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01012297-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01012297
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II Gem+Doce+Bev
- regimen
- Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10. Bevacizumab: Given IV Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC
- analyzed count
- 53
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01012297-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01012297
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm I Gem+Doce+Placebo
- regimen
- Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC Placebo: Given IV
- analyzed count
- 54
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01012297-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01012297
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm II Gem+Doce+Bev
- regimen
- Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10. Bevacizumab: Given IV Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC
- analyzed count
- 53
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01012297-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01012297
- harm key
- EG000
- source section id
- NCT01012297-ae
- event group key
- EG000
- event group label
- Arm I
- serious affected
- 17
- serious at risk
- 54
- other affected
- 51
- other at risk
- 54
- frequency threshold
- 0
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01012297
- harm key
- EG001
- source section id
- NCT01012297-ae
- event group key
- EG001
- event group label
- Arm II
- serious affected
- 21
- serious at risk
- 53
- other affected
- 51
- other at risk
- 53
- frequency threshold
- 0
- 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