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NCT02584309 · OUTCOME

Percentage of Patients With Heart Failure or Cardiomyopathy

Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma · Source last updated 2023-11-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 12 months

What was measured

* 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.

Groups in this outcome

Arm 1: Doxorubicin and Upfront Dexrazoxane

* 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..

Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)

* 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm 1: Doxorubicin and Upfront Dexrazoxane62
Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)10

Reported measurements

Moderate cancer therapy related cardiac dysfunction (CTRCD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1: Doxorubicin and Upfront Dexrazoxane4Not reportedNot reportedNot reportedNot reported
Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)0Not reportedNot reportedNot reportedNot reported
Mild cancer therapy related cardiac dysfunction (CTRCD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1: Doxorubicin and Upfront Dexrazoxane25Not reportedNot reportedNot reportedNot reported
Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)4Not reportedNot reportedNot reportedNot reported
Heart failure with mildly reduced ejection fraction (HfmrEF)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1: Doxorubicin and Upfront Dexrazoxane0Not reportedNot reportedNot reportedNot reported
Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)0Not reportedNot reportedNot reportedNot reported
Heart failure with preserved ejection fraction (HFpEF)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1: Doxorubicin and Upfront Dexrazoxane17Not reportedNot reportedNot reportedNot reported
Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
    title
    Moderate cancer therapy related cardiac dysfunction (CTRCD)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        4
    title
    Mild cancer therapy related cardiac dysfunction (CTRCD)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Heart failure with mildly reduced ejection fraction (HfmrEF)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        1
    title
    Heart failure with preserved ejection fraction (HFpEF)
denoms
  1. counts
    1. group Id
      OG000
      value
      62
    2. group Id
      OG001
      value
      10
    units
    Participants
description
* 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.
groups
  1. description
    * 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..
    id
    OG000
    title
    Arm 1: Doxorubicin and Upfront Dexrazoxane
  2. description
    * 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.
    id
    OG001
    title
    Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 12 months
title
Percentage of Patients With Heart Failure or Cardiomyopathy
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice