NCT02584309 · OUTCOME

Cardiac-related Mortality

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

Death due to cardiovascular while on study (heart failure, myocardial infarction, fatal arrhythmia).

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

Group	Source count
Arm 1: Doxorubicin and Upfront Dexrazoxane	62
Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)	10

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Doxorubicin and Upfront Dexrazoxane	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0

denoms

counts
group Id
OG000
value
62
group Id
OG001
value
10
units
Participants

description

Death due to cardiovascular while on study (heart failure, myocardial infarction, fatal arrhythmia).

groups

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
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

Cardiac-related Mortality

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice