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A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy

1 Year
18 Years
Open (Enrolling)
Ototoxicity, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy


- Determine the optimal criteria for determination of ototoxicity in younger cancer
patients treated with cisplatin.

- Determine the feasibility of including ultrahigh frequency and evoked otoacoustic
emission testing as adjunctive measures of ototoxicity.

- Determine the feasibility and necessity of central review of audiometry data.

OUTLINE: This is a multicenter, prospective, cohort study.

Patients undergo hearing tests (conventional, otoscopy, ultrahigh frequency, and otoacoustic
emission testing) before the first course of planned cisplatin, before each subsequent
course of cisplatin, and 4 weeks after the last dose of cisplatin.

Patients who are scheduled to receive hematopoietic progenitor stem cell transplantation
undergo hearing tests before the transplantation and 4 weeks after transplantation.

PROJECTED ACCRUAL: A total of 282 patients will be accrued for this study.

Inclusion Criteria


- Planning to undergo treatment with any cisplatin-containing therapeutic regimen for

- Treatment does not need to be on a COG therapeutic study

- Planning to enroll on clinical trial ACCL0431


- Not specified


- See Disease Characteristics

- No prior cisplatin

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria

Outcome Time Frame:

Length of study

Safety Issue:


Principal Investigator

Lillian Sung, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Hospital for Sick Children


United States: Federal Government

Study ID:




Start Date:

May 2007

Completion Date:

Related Keywords:

  • Ototoxicity
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • ototoxicity
  • unspecified childhood solid tumor, protocol specific



National Naval Medical Center Bethesda, Maryland  20889
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Hurley Medical Center Flint, Michigan  48503
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Bronson Methodist Hospital Kalamazoo, Michigan  49007
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Newark Beth Israel Medical Center Newark, New Jersey  07112
New York Medical College Valhalla, New York  10595
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Children's Mercy Hospital Kansas City, Missouri  64108
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
Nemours Children's Clinic Jacksonville, Florida  32207
All Children's Hospital St. Petersburg, Florida  33701
Saint Jude Midwest Affiliate Peoria, Illinois  61637
Children's Hospital of New Orleans New Orleans, Louisiana  70118
Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
Driscoll Children's Hospital Corpus Christi, Texas  78466
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
Southern California Permanente Medical Group Downey, California  90242
Children's Hospital Central California Madera, California  93638-8762
Kosair Children's Hospital Louisville, Kentucky  40202-3830
East Tennessee Children's Hospital Knoxville, Tennessee  37901
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Carol G. Simon Cancer Center at Morristown Memorial Hospital Morristown, New Jersey  07962
Yale Cancer Center New Haven, Connecticut  06520-8028
Lee Cancer Care of Lee Memorial Health System Fort Myers, Florida  33901
Nemours Children's Clinic - Orlando Orlando, Florida  32806
Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando, Florida  32803-1273
St. Joseph's Cancer Institute at St. Joseph's Hospital Tampa, Florida  33607
Blank Children's Hospital Des Moines, Iowa  50309
Hackensack University Medical Center Cancer Center Hackensack, New Jersey  07601
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Rainbow Babies and Children's Hospital Cleveland, Ohio  44106-5000
Rhode Island Hospital Comprehensive Cancer Center Providence, Rhode Island  02903
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Methodist Children's Hospital of South Texas San Antonio, Texas  78229-3993
Providence Cancer Center at Sacred Heart Medical Center Spokane, Washington  99220-2555
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Childrens Hospital Los Angeles Los Angeles, California  90027
Lucile Packard Children's Hospital at Stanford University Medical Center Palo Alto, California  95798
Rady Children's Hospital - San Diego San Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Alfred I. duPont Hospital for Children Wilmington, Delaware  19803
Mountain States Tumor Institute at St. Luke's Regional Medical Center Boise, Idaho  83712-6297
University of Illinois Cancer Center Chicago, Illinois  60612-7243
Tulane Cancer Center Office of Clinical Research Alexandria, Louisiana  71315-3198
C.S. Mott Children's Hospital at University of Michigan Medical Center Ann Arbor, Michigan  48109-0286
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota  55404
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York, New York  10032
Nationwide Children's Hospital Columbus, Ohio  43205-2696
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Knight Cancer Institute at Oregon Health and Science University Portland, Oregon  97239-3098
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania  15213
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Riley's Children Cancer Center at Riley Hospital for Children Indianapolis, Indiana  46202-5225
UAB Comprehensive Cancer Center Birmingham, Alabama  35294
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania  18017
Duke Cancer Institute Durham, North Carolina  27710
Connecticut Children's Medical Center Hartford, Connecticut  06106
Nemours Children's Clinic - Pensacola Pensacola, Florida  32504
Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan  49503
Legacy Emanuel Children's Hospital Portland, Oregon  97227