Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin

Sponsor

Children's Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00458887

Collaborator

National Cancer Institute (NCI) (NIH)

301

Enrollment

Locations

118

Duration (Months)

3.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: New ways to find out about hearing loss after treatment with chemotherapy may improve the ability to plan cancer treatment and may help patients live more comfortably.

PURPOSE: This clinical trial is assessing ear damage in young cancer patients treated with cisplatin.

Condition or Disease	Intervention/Treatment	Phase
Ototoxicity Unspecified Childhood Solid Tumor, Protocol Specific	Procedure: management of therapy complications

Detailed Description

OBJECTIVES:

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.

Study Design

Study Type:

Observational

Actual Enrollment :

301 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Feb 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Ancillary/Correlative (ototoxicity assessment) Patients undergo hearing tests (conventional, otoscopy, ultrahigh frequency, and otoacoustic emission testing) for management of therapy complications 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 for management of therapy complications before the transplantation and 4 weeks after transplantation.	Procedure: management of therapy complications Undergo hearing tests Other Names: complications of therapy, management of

Arm

Intervention/Treatment

Ancillary/Correlative (ototoxicity assessment)

Patients undergo hearing tests (conventional, otoscopy, ultrahigh frequency, and otoacoustic emission testing) for management of therapy complications 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 for management of therapy complications before the transplantation and 4 weeks after transplantation.

Procedure: management of therapy complications

Undergo hearing tests

Other Names:

complications of therapy, management of

Outcome Measures

Primary Outcome Measures

Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria [Length of study]
Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing [Length of study]
Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations) [Length of Study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Planning to undergo treatment with any cisplatin-containing therapeutic regimen for cancer
Treatment does not need to be on a COG therapeutic study
Planning to enroll on clinical trial ACCL0431

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior cisplatin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Comprehensive Cancer Center	Birmingham	Alabama	United States	35294
2	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
3	Childrens Hospital Los Angeles	Los Angeles	California	United States	90027
4	Southern California Permanente Medical Group	Los Angeles	California	United States	90027
5	Children's Hospital Central California	Madera	California	United States	93638-8762
6	Lucile Packard Children's Hospital at Stanford University Medical Center	Palo Alto	California	United States	95798
7	Rady Children's Hospital - San Diego	San Diego	California	United States	92123-4282
8	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California	United States	94115
9	Connecticut Children's Medical Center	Hartford	Connecticut	United States	06106
10	Yale Cancer Center	New Haven	Connecticut	United States	06520-8028
11	Alfred I. duPont Hospital for Children	Wilmington	Delaware	United States	19803
12	Lee Cancer Care of Lee Memorial Health System	Fort Myers	Florida	United States	33901
13	Nemours Children's Clinic	Jacksonville	Florida	United States	32207
14	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida	United States	33136
15	Florida Hospital Cancer Institute at Florida Hospital Orlando	Orlando	Florida	United States	32803-1273
16	Nemours Children's Clinic - Orlando	Orlando	Florida	United States	32806
17	Nemours Children's Clinic - Pensacola	Pensacola	Florida	United States	32504
18	All Children's Hospital	Saint Petersburg	Florida	United States	33701
19	St. Joseph's Cancer Institute at St. Joseph's Hospital	Tampa	Florida	United States	33607
20	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813
21	Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho	United States	83712-6297
22	University of Illinois Cancer Center	Chicago	Illinois	United States	60612-7243
23	Saint Jude Midwest Affiliate	Peoria	Illinois	United States	61603
24	Riley's Children Cancer Center at Riley Hospital for Children	Indianapolis	Indiana	United States	46202
25	Blank Children's Hospital	Des Moines	Iowa	United States	50309
26	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
27	Kosair Children's Hospital	Louisville	Kentucky	United States	40232
28	Tulane Cancer Center Office of Clinical Research	Alexandria	Louisiana	United States	71315-3198
29	Children's Hospital of New Orleans	New Orleans	Louisiana	United States	70118
30	National Naval Medical Center	Bethesda	Maryland	United States	20889-5600
31	C.S. Mott Children's Hospital at University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109-0286
32	Hurley Medical Center	Flint	Michigan	United States	48503
33	Helen DeVos Children's Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
34	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007-5381
35	Children's Hospitals and Clinics of Minnesota - Minneapolis	Minneapolis	Minnesota	United States	55404
36	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota	United States	55455
37	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
38	Children's Mercy Hospital	Kansas City	Missouri	United States	64108
39	Cardinal Glennon Children's Hospital	St. Louis	Missouri	United States	63104
40	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89109-2306
41	Hackensack University Medical Center Cancer Center	Hackensack	New Jersey	United States	07601
42	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
43	Carol G. Simon Cancer Center at Morristown Memorial Hospital	Summit	New Jersey	United States	07901
44	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87131-5636
45	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York	United States	10032
46	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
47	New York Medical College	Valhalla	New York	United States	10595
48	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina	United States	28233-3549
49	Duke Cancer Institute	Durham	North Carolina	United States	27710
50	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
51	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229-3039
52	Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106-5000
53	Nationwide Children's Hospital	Columbus	Ohio	United States	43205-2696
54	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
55	Legacy Emanuel Children's Hospital	Portland	Oregon	United States	97227
56	Knight Cancer Institute at Oregon Health and Science University	Portland	Oregon	United States	97239-3098
57	Lehigh Valley Hospital - Muhlenberg	Bethlehem	Pennsylvania	United States	18017
58	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania	United States	17822-0001
59	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15213
60	Rhode Island Hospital Comprehensive Cancer Center	Providence	Rhode Island	United States	02903
61	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota	United States	57117-5039
62	East Tennessee Children's Hospital	Knoxville	Tennessee	United States	37916
63	Driscoll Children's Hospital	Corpus Christi	Texas	United States	78411
64	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390
65	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78207
66	Methodist Children's Hospital of South Texas	San Antonio	Texas	United States	78229-3993
67	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042-3300
68	Children's Hospital of The King's Daughters	Norfolk	Virginia	United States	23507-1971
69	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia	United States	23298-0037
70	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington	United States	98105
71	Providence Cancer Center at Sacred Heart Medical Center	Spokane	Washington	United States	99220-2555
72	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
73	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
74	Princess Margaret Hospital for Children	Perth	Western Australia	Australia	6001
75	Children's and Women's Hospital of British Columbia	Vancouver	British Columbia	Canada	V6H 3V4
76	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
77	IWK Health Centre	Halifax	Nova Scotia	Canada	B3J 3G9
78	Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8
79	Hopital Sainte Justine	Montreal	Quebec	Canada	H3T 1C5
80	Saskatoon Cancer Centre at the University of Saskatchewan	Saskatoon	Saskatchewan	Canada	S7N 4H4
81	Centre Hospitalier Universitaire de Quebec	Quebec		Canada	G1V 4G2

Sponsors and Collaborators

Children's Oncology Group
National Cancer Institute (NCI)

Investigators

Study Chair: Lillian Sung, MD, PhD, The Hospital for Sick Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Oncology Group

ClinicalTrials.gov Identifier:

NCT00458887

Other Study ID Numbers:

ACCL05C1
COG-ACCL05C1
CDR0000538247

First Posted:

Apr 11, 2007

Last Update Posted:

Mar 13, 2017

Last Verified:

Mar 1, 2017

Keywords provided by Children's Oncology Group

ototoxicity

unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:

Ototoxicity

Study Results

No Results Posted as of Mar 13, 2017