TriangleNCT01343277 · STUDY IN CONTEXT
A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or 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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.
Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.
The objective response rate (ORR) is defined as the percentage of participants who achieved a Complete response (CR) or partial response (PR) as best responses. according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.
Duration of response is defined as the time from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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
- NCT01343277
- trial label
- A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or 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
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01343277
- outcome key
- om-0005
- source section id
- NCT01343277-om-0005
- source outcome index
- 5
- endpoint
- Overall Survival (OS)
- endpoint definition
- The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
- time origin
- approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Analysis population included all the randomized participants up to up to final analysis cut-off date (05 January 2015).
- 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
- NCT01343277
- outcome key
- om-0000
- source section id
- NCT01343277-om-0000
- source outcome index
- 0
- endpoint
- Progression-Free Survival (PFS)
- endpoint definition
- The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.
- time origin
- approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). "N" (number of participants analyzed) signifies the participants evaluable for this measure.
- 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
- NCT01343277
- outcome key
- om-0001
- source section id
- NCT01343277-om-0001
- source outcome index
- 1
- endpoint
- Time to Progression
- endpoint definition
- Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.
- time origin
- approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). "N" (number of participants analyzed) signifies the participants evaluable for this measure.
- 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
- NCT01343277
- outcome key
- om-0002
- source section id
- NCT01343277-om-0002
- source outcome index
- 2
- endpoint
- Objective Response Rate
- endpoint definition
- The objective response rate (ORR) is defined as the percentage of participants who achieved a Complete response (CR) or partial response (PR) as best responses. according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.
- time origin
- approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). "N" (number of participants analyzed) signifies the participants evaluable for this measure.
- 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
- NCT01343277
- outcome key
- om-0003
- source section id
- NCT01343277-om-0003
- source outcome index
- 3
- endpoint
- Duration of Response
- endpoint definition
- Duration of response is defined as the time from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.
- time origin
- approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). "N" (number of participants analyzed) signifies the participants evaluable for this measure.
- 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
- NCT01343277
- outcome key
- om-0004
- source section id
- NCT01343277-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- endpoint definition
- An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- time origin
- approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015])
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety population included all the treated participants.
- 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
- NCT01343277
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Trabectedin
- regimen
- Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
- analyzed count
- 345
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01343277-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01343277
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Dacarbazine
- regimen
- Dacarbazine at a dose of 1 gram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
- analyzed count
- 173
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01343277-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01343277
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Trabectedin
- regimen
- Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
- analyzed count
- 345
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01343277-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01343277
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Dacarbazine
- regimen
- Dacarbazine at a dose of 1 gram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
- analyzed count
- 173
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01343277-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01343277
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Trabectedin
- regimen
- Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
- analyzed count
- 345
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01343277-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01343277
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Dacarbazine
- regimen
- Dacarbazine at a dose of 1 gram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
- analyzed count
- 173
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01343277-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01343277
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Trabectedin
- regimen
- Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01343277-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01343277
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Dacarbazine
- regimen
- Dacarbazine at a dose of 1 gram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01343277-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01343277
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Trabectedin
- regimen
- Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
- analyzed count
- 378
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01343277-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01343277
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Dacarbazine
- regimen
- Dacarbazine at a dose of 1 gram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
- analyzed count
- 172
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01343277-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01343277
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Trabectedin
- regimen
- Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
- analyzed count
- 384
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01343277-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01343277
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Dacarbazine
- regimen
- Dacarbazine at a dose of 1 gram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
- analyzed count
- 193
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01343277-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01343277
- harm key
- EG000
- source section id
- NCT01343277-ae
- event group key
- EG000
- event group label
- Trabectedin
- serious affected
- 155
- serious at risk
- 378
- other affected
- 375
- other at risk
- 378
- frequency threshold
- 5
- collection period
- approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]
- event definition
- Safety population included all the treated participants.
- 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
- NCT01343277
- harm key
- EG001
- source section id
- NCT01343277-ae
- event group key
- EG001
- event group label
- Dacarbazine
- serious affected
- 52
- serious at risk
- 172
- other affected
- 166
- other at risk
- 172
- frequency threshold
- 5
- collection period
- approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]
- event definition
- Safety population included all the treated participants.
- 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