A Phase 2 interventional study of Dexrazoxane and Doxorubicin in Sarcoma, Soft Tissue, Soft Tissue Sarcoma and Undifferentiated Pleomorphic Sarcoma, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment
The purpose of this research study is to look at whether giving a drug called dexrazoxane with standard of care doxorubicin affects the progression of the disease. Dexrazoxane is often given at the same time as doxorubicin to help reduce the incidence and severity of disease of the heart muscle (which can be caused by doxorubicin).
In January 2019 Eli Lilly and Company reported that the results of the Phase 3 study of olaratumab (Lartruvo), in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma, did not confirm the clinical benefit of olaratumab in combination with doxorubicin as compared to doxorubicin alone. Therefore olaratumab is being removed from the front line standard of care regimen. Amendment #9 was made to the protocol to reflect these changes to the standard of care treatment.
1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.
This study's enrollment of 73 is above the median of 40 across 1,255 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
confirmed grade 2 or 3 soft tissue sarcoma that is unresectable or . Surgery for primary or metastatic disease after chemotherapy following a response is allowed. Patients with the following tumor types are eligible:
Adequate organ function defined as:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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..
Drug: Dexrazoxane · Drug: Doxorubicin
* 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.
Drug: Dexrazoxane · Drug: Doxorubicin
Also known as: Zinecard®, Totect®
Also known as: Adriamycin, Hydroxydaunomycin Hydrochloride, Hydroxydoxorubicin Hydrochloride, Rubex
Progression-free Survival (PFS) (Arm 1 Only)
* 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 frame: Up to 5 years
Cardiac-related Mortality
Death due to cardiovascular while on study (heart failure, myocardial infarction, fatal arrhythmia).
Time frame: Up to 12 months
Percentage of Patients With Heart Failure or Cardiomyopathy
* 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 frame: Up to 12 months
Ability of 3D Echocardiogram to Serve as an Early Marker of Cardiac Dysfunction Compared to 2D Echocardiogram Modified Simpson's Biplane Method of LVEF
* 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 frame: Baseline and day 1 of each odd numbered cycle (each cycle is 21 days) up to 1 year
Early Detection of Cardiac Dysfunction by 2D Echocardiography Ventricular Strain Compared to 2D Echocardiography Ejection Fraction
* 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 frame: Baseline and day 1 of each odd numbered cycle (each cycle is 21 days) up to 1 year
| Milestone | Arm 1: Doxorubicin and Upfront Dexrazoxane | Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | Unassigned Arm |
|---|---|---|---|
| Started | 62 | 10 | 1 |
| Completed | 62 | 10 | 0 |
| Not completed | 0 | 0 | 1 |
* 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).
| months | Arm 1: Doxorubicin and Upfront Dexrazoxane | Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) |
|---|---|---|
| Progression-free Survival (PFS) (Arm 1 Only) | 5.48 (4.01 to 7.37) | — |
Death due to cardiovascular while on study (heart failure, myocardial infarction, fatal arrhythmia).
| Participants | Arm 1: Doxorubicin and Upfront Dexrazoxane | Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) |
|---|---|---|
| Cardiac-related Mortality | 0 | 0 |
* 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.
| Participants | Arm 1: Doxorubicin and Upfront Dexrazoxane | Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) |
|---|---|---|
| Moderate cancer therapy related cardiac dysfunction (CTRCD) | 4 | 0 |
| Mild cancer therapy related cardiac dysfunction (CTRCD) | 25 | 4 |
| Heart failure with mildly reduced ejection fraction (HfmrEF) | 0 | 0 |
| Heart failure with preserved ejection fraction (HFpEF) | 17 | 1 |
* 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%.
| Participants | Arm 1: Doxorubicin and Upfront Dexrazoxane | Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) |
|---|---|---|
| Patients with moderate CTRCD by 2D echo — Early dysfunction noted on 3D Echo | 0 | 0 |
| Patients with moderate CTRCD by 2D echo — No early dysfunction noted on 3D echo | 1 | 0 |
| Patients without moderate CTRCD by 2D echo — Early dysfunction noted on 3D Echo | 7 | 0 |
| Patients without moderate CTRCD by 2D echo — No early dysfunction noted on 3D echo | 38 | 9 |
* 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%.
| Participants | Arm 1: Doxorubicin and Upfront Dexrazoxane | Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) |
|---|---|---|
| Patients with moderate CTRCD by 2D echo — Early dysfunction noted on 2D GLS | 1 | 0 |
| Patients with moderate CTRCD by 2D echo — No early dysfunction noted on 2D GLS | 1 | 0 |
| Patients without moderate CTRCD by 2D echo — Early dysfunction noted on 2D GLS | 6 | 2 |
| Patients without moderate CTRCD by 2D echo — No early dysfunction noted on 2D GLS | 40 | 8 |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Doxorubicin and Upfront Dexrazoxane | 52/62 (83.9%) | 17/62 (27.4%) | 62/62 (100%) |
| Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | 5/10 (50%) | 1/10 (10%) | 10/10 (100%) |
| Event | Arm 1: Doxorubicin and Upfront Dexrazoxane | Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) |
|---|---|---|
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/62 | 1/10 |
| Febrile neutropeniaBlood and lymphatic system disorders | 5/62 | 0/10 |
| SepsisInfections and infestations | 3/62 | 0/10 |
| Abdominal painGastrointestinal disorders | 2/62 | 0/10 |
| Lower gastrointestinal hemorrhageGastrointestinal disorders | 2/62 | 0/10 |
| Myocardial infarctionCardiac disorders | 1/62 | 0/10 |
| Upper gastrointestinal hemorrhageGastrointestinal disorders | 1/62 | 0/10 |
| FeverGeneral disorders | 1/62 | 0/10 |
| Non-cardiac chest painGeneral disorders | 1/62 | 0/10 |
| Sudden death NOSGeneral disorders | 1/62 | 0/10 |
| Event | Arm 1: Doxorubicin and Upfront Dexrazoxane | Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 58/62 | 10/10 |
| AlopeciaSkin and subcutaneous tissue disorders | 21/62 | 10/10 |
| Lymphocytes decreasedInvestigations | 48/62 | 9/10 |
| NauseaGastrointestinal disorders | 24/62 | 8/10 |
| FatigueGeneral disorders | 49/62 | 7/10 |
| HypocalcemiaMetabolism and nutrition disorders | 26/62 | 7/10 |
| Neutrophil count decreasedInvestigations | 43/62 | 3/10 |
| ConstipationGastrointestinal disorders | 31/62 | 6/10 |
| HypokalemiaMetabolism and nutrition disorders | 19/62 | 6/10 |
| HypoalbuminemiaMetabolism and nutrition disorders | 33/62 | 2/10 |
| Age, Continuous(years) | Arm 1: Doxorubicin and Upfront Dexrazoxane | Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | Unassigned Arm | Total |
|---|---|---|---|---|
| Median | 65 (23 to 85) | 62.5 (55 to 71) | 54 (54 to 54) | 65 (23 to 85) |
| Sex: Female, Male(Participants) | Arm 1: Doxorubicin and Upfront Dexrazoxane | Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | Unassigned Arm | Total |
|---|---|---|---|---|
| Female | 33 | 5 | 0 | 38 |
| Male | 29 | 5 | 1 | 35 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1: Doxorubicin and Upfront Dexrazoxane | Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | Unassigned Arm | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 1 |
| Not Hispanic or Latino | 61 | 10 | 1 | 72 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm 1: Doxorubicin and Upfront Dexrazoxane | Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | Unassigned Arm | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 8 | 0 | 0 | 8 |
| White | 54 | 10 | 1 | 65 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm 1: Doxorubicin and Upfront Dexrazoxane | Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | Unassigned Arm | Total |
|---|---|---|---|---|
| United States | 62 | 10 | 1 | 73 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drugs tested here: Dexrazoxane · Doxorubicin
Washington University School of Medicine →