TriangleNCT02584309 · STUDY IN CONTEXT
Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma
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
* PFS is defined as the time from on study to the first occurrence of progression or death, whichever occurs first. * If no event exists, the PFS will be censored at the last follow-up. * Progressive disease - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Death due to cardiovascular while on study (heart failure, myocardial infarction, fatal arrhythmia).
* Cardiomyopathy is now referred to as cancer therapy related cardiac dysfunction (CTRCD) by the recent consensus statement of the International Cardio-Oncology Society. Moderate CTRCD is defined as \>10% ejection fraction drop to \<50%. Mild CTRCD is defined as drop in ≥15% ventricular strain or if no ventricular strain, a drop in ejection fraction of ≥50%. * Heart failure is defined according to the recent Universal Definition and Classification of Heart Failure: A Report of the Heart Failure Society of America, Heart Failure Association of the European Society of Cardiology, Japanese Heart Failure Society and Writing Committee of the Universal Definition of Heart Failure.
* Cardiac dysfunction for this outcome measure is defined as moderate cancer therapy related cardiac dysfunction (CTRCD) as assessed by 2D Echocardiogram Modified Simpson's Biplane Method of LVEF. Moderate CTRCD is defined as \>10% ejection fraction drop to \<50%. * 3D echocardiograms were reviewed for evidence of cardiac dysfunction prior to onset of Moderate CTRCD by 2D echocardiogram. Dysfunction on 3D Echo was defined as \>10% ejection fraction drop to \<50%.
* Cardiac dysfunction for this outcome measure is defined as moderate cancer therapy related cardiac dysfunction (CTRCD) by 2D Echocardiogram Modified Simpson's Biplane Method of LVEF. Moderate CTRCD is defined as \>10% ejection fraction drop to \<50%. * Patients were assessed for early evidence of dysfunction by strain defined as a relative drop in global longitudinal strain (GLS) by 15% and GLS \> -17%.
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-fibrosarcoma
- nct id
- NCT02584309
- trial label
- Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma
- 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
- 5
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0000
- source section id
- NCT02584309-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival (PFS) (Arm 1 Only)
- endpoint definition
- * PFS is defined as the time from on study to the first occurrence of progression or death, whichever occurs first. * If no event exists, the PFS will be censored at the last follow-up. * Progressive disease - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
- time origin
- Up to 5 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants enrolled in Arm 2 are not evaluable for this outcome 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-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0001
- source section id
- NCT02584309-om-0001
- source outcome index
- 1
- endpoint
- Cardiac-related Mortality
- endpoint definition
- Death due to cardiovascular while on study (heart failure, myocardial infarction, fatal arrhythmia).
- time origin
- Up to 12 months
- 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-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0002
- source section id
- NCT02584309-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Patients With Heart Failure or Cardiomyopathy
- endpoint definition
- * Cardiomyopathy is now referred to as cancer therapy related cardiac dysfunction (CTRCD) by the recent consensus statement of the International Cardio-Oncology Society. Moderate CTRCD is defined as \>10% ejection fraction drop to \<50%. Mild CTRCD is defined as drop in ≥15% ventricular strain or if no ventricular strain, a drop in ejection fraction of ≥50%. * Heart failure is defined according to the recent Universal Definition and Classification of Heart Failure: A Report of the Heart Failure Society of America, Heart Failure Association of the European Society of Cardiology, Japanese Heart Failure Society and Writing Committee of the Universal Definition of Heart Failure.
- time origin
- Up to 12 months
- 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-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0003
- source section id
- NCT02584309-om-0003
- source outcome index
- 3
- endpoint
- Ability of 3D Echocardiogram to Serve as an Early Marker of Cardiac Dysfunction Compared to 2D Echocardiogram Modified Simpson's Biplane Method of LVEF
- endpoint definition
- * Cardiac dysfunction for this outcome measure is defined as moderate cancer therapy related cardiac dysfunction (CTRCD) as assessed by 2D Echocardiogram Modified Simpson's Biplane Method of LVEF. Moderate CTRCD is defined as \>10% ejection fraction drop to \<50%. * 3D echocardiograms were reviewed for evidence of cardiac dysfunction prior to onset of Moderate CTRCD by 2D echocardiogram. Dysfunction on 3D Echo was defined as \>10% ejection fraction drop to \<50%.
- time origin
- Baseline and day 1 of each odd numbered cycle (each cycle is 21 days) up to 1 year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 13 participants were removed due to lack of analyzable 3D echo prior to onset of Moderate CTRCD or end of study.
- 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-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0004
- source section id
- NCT02584309-om-0004
- source outcome index
- 4
- endpoint
- Early Detection of Cardiac Dysfunction by 2D Echocardiography Ventricular Strain Compared to 2D Echocardiography Ejection Fraction
- endpoint definition
- * Cardiac dysfunction for this outcome measure is defined as moderate cancer therapy related cardiac dysfunction (CTRCD) by 2D Echocardiogram Modified Simpson's Biplane Method of LVEF. Moderate CTRCD is defined as \>10% ejection fraction drop to \<50%. * Patients were assessed for early evidence of dysfunction by strain defined as a relative drop in global longitudinal strain (GLS) by 15% and GLS \> -17%.
- time origin
- Baseline and day 1 of each odd numbered cycle (each cycle is 21 days) up to 1 year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants were not included in this outcome measure if they did not have GLS.
- 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-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm 1: Doxorubicin and Upfront Dexrazoxane
- regimen
- * Dexrazoxane will be given intravenously on an outpatient basis over 15 minutes on each day that doxorubicin is given. * Dexrazoxane should be given no more than 30 minutes prior to administration of doxorubicin, which is typically given on Day 1 of a 21-day cycle. * Dosing is a 10:1 ratio of dexrazoxane to doxorubicin; doxorubicin is typically given at 75 mg/m2, so dexrazoxane dosing would be 750 mg/m2. * In the event of a national shortage of dexrazoxane, 72-hour infusional doxorubicin can be used instead of dexrazoxane and bolus doxorubicin..
- analyzed count
- 62
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02584309-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)
- regimen
- * Doxorubicin is given as standard of care. Doxorubicin is typically given at 75 mg/m2 on Day 1 of a 21-day cycle. * Starting with cycle 5, standard of care dexrazoxane (75 mg/m2) will be given for 4 cycles. * The last 10 patients enrolled after completion of enrollment to Arm 1 will be enrolled to Arm 2.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02584309-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm 1: Doxorubicin and Upfront Dexrazoxane
- regimen
- * Dexrazoxane will be given intravenously on an outpatient basis over 15 minutes on each day that doxorubicin is given. * Dexrazoxane should be given no more than 30 minutes prior to administration of doxorubicin, which is typically given on Day 1 of a 21-day cycle. * Dosing is a 10:1 ratio of dexrazoxane to doxorubicin; doxorubicin is typically given at 75 mg/m2, so dexrazoxane dosing would be 750 mg/m2. * In the event of a national shortage of dexrazoxane, 72-hour infusional doxorubicin can be used instead of dexrazoxane and bolus doxorubicin..
- analyzed count
- 62
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02584309-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)
- regimen
- * Doxorubicin is given as standard of care. Doxorubicin is typically given at 75 mg/m2 on Day 1 of a 21-day cycle. * Starting with cycle 5, standard of care dexrazoxane (75 mg/m2) will be given for 4 cycles. * The last 10 patients enrolled after completion of enrollment to Arm 1 will be enrolled to Arm 2.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02584309-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm 1: Doxorubicin and Upfront Dexrazoxane
- regimen
- * Dexrazoxane will be given intravenously on an outpatient basis over 15 minutes on each day that doxorubicin is given. * Dexrazoxane should be given no more than 30 minutes prior to administration of doxorubicin, which is typically given on Day 1 of a 21-day cycle. * Dosing is a 10:1 ratio of dexrazoxane to doxorubicin; doxorubicin is typically given at 75 mg/m2, so dexrazoxane dosing would be 750 mg/m2. * In the event of a national shortage of dexrazoxane, 72-hour infusional doxorubicin can be used instead of dexrazoxane and bolus doxorubicin..
- analyzed count
- 62
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02584309-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)
- regimen
- * Doxorubicin is given as standard of care. Doxorubicin is typically given at 75 mg/m2 on Day 1 of a 21-day cycle. * Starting with cycle 5, standard of care dexrazoxane (75 mg/m2) will be given for 4 cycles. * The last 10 patients enrolled after completion of enrollment to Arm 1 will be enrolled to Arm 2.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02584309-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm 1: Doxorubicin and Upfront Dexrazoxane
- regimen
- * Dexrazoxane will be given intravenously on an outpatient basis over 15 minutes on each day that doxorubicin is given. * Dexrazoxane should be given no more than 30 minutes prior to administration of doxorubicin, which is typically given on Day 1 of a 21-day cycle. * Dosing is a 10:1 ratio of dexrazoxane to doxorubicin; doxorubicin is typically given at 75 mg/m2, so dexrazoxane dosing would be 750 mg/m2. * In the event of a national shortage of dexrazoxane, 72-hour infusional doxorubicin can be used instead of dexrazoxane and bolus doxorubicin..
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02584309-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)
- regimen
- * Doxorubicin is given as standard of care. Doxorubicin is typically given at 75 mg/m2 on Day 1 of a 21-day cycle. * Starting with cycle 5, standard of care dexrazoxane (75 mg/m2) will be given for 4 cycles. * The last 10 patients enrolled after completion of enrollment to Arm 1 will be enrolled to Arm 2.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02584309-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm 1: Doxorubicin and Upfront Dexrazoxane
- regimen
- * Dexrazoxane will be given intravenously on an outpatient basis over 15 minutes on each day that doxorubicin is given. * Dexrazoxane should be given no more than 30 minutes prior to administration of doxorubicin, which is typically given on Day 1 of a 21-day cycle. * Dosing is a 10:1 ratio of dexrazoxane to doxorubicin; doxorubicin is typically given at 75 mg/m2, so dexrazoxane dosing would be 750 mg/m2. * In the event of a national shortage of dexrazoxane, 72-hour infusional doxorubicin can be used instead of dexrazoxane and bolus doxorubicin.
- analyzed count
- 48
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02584309-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-fibrosarcoma
- nct id
- NCT02584309
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)
- regimen
- * Doxorubicin is given as standard of care. Doxorubicin is typically given at 75 mg/m2 on Day 1 of a 21-day cycle. * Starting with cycle 5, standard of care dexrazoxane (75 mg/m2) will be given for 4 cycles. * The last 10 patients enrolled after completion of enrollment to Arm 1 will be enrolled to Arm 2.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02584309-om-0004#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-fibrosarcoma
- nct id
- NCT02584309
- harm key
- EG000
- source section id
- NCT02584309-ae
- event group key
- EG000
- event group label
- Arm 1: Doxorubicin and Upfront Dexrazoxane
- serious affected
- 17
- serious at risk
- 62
- other affected
- 62
- other at risk
- 62
- frequency threshold
- 0
- collection period
- Adverse events were collected from start of treatment through 30 days following last day of treatment. The median follow-up was 142 days (full range 9-1214 days). All-cause mortality was collected from start of treatment through completion of follow-up. The median follow-up was 529 days (full range 9-2188 days).
- 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-fibrosarcoma
- nct id
- NCT02584309
- harm key
- EG001
- source section id
- NCT02584309-ae
- event group key
- EG001
- event group label
- Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)
- serious affected
- 1
- serious at risk
- 10
- other affected
- 10
- other at risk
- 10
- frequency threshold
- 0
- collection period
- Adverse events were collected from start of treatment through 30 days following last day of treatment. The median follow-up was 142 days (full range 9-1214 days). All-cause mortality was collected from start of treatment through completion of follow-up. The median follow-up was 529 days (full range 9-2188 days).
- 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