OtotoxicityNCT00458887
Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin
An observational study of Ototoxicity and Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Oncology Group at 81 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Ototoxicity, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 301 participants
- Where
- 81 sitesin 3 countries
- Study dates
- May 2007to 28 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients planning to undergo treatment with any cisplatin-containing therapeutic regimen for cancer or planning to enroll on clinical trial ACCL0431
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
Trial locations and contacts
81 sites in 3 countries.
81 sites in 3 countries
United States73 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-5636
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
National Naval Medical Center
Bethesda, Maryland, 20889-5600
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, 83712-6297
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, 28233-3549
University of Illinois Cancer Center
Chicago, Illinois, 60612-7243
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106-5000
Nationwide Children's Hospital
Columbus, Ohio, 43205-2696
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, 17822-0001
Blank Children's Hospital
Des Moines, Iowa, 50309
Duke Cancer Institute
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042-3300
Hurley Medical Center
Flint, Michigan, 48503
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, 33901
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, 07601
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
Riley's Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, 46202
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002
Nemours Children's Clinic
Jacksonville, Florida, 32207
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007-5381
Children's Mercy Hospital
Kansas City, Missouri, 64108
East Tennessee Children's Hospital
Knoxville, Tennessee, 37916
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89109-2306
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Childrens Hospital Los Angeles
Los Angeles, California, 90027
Southern California Permanente Medical Group
Los Angeles, California, 90027
Kosair Children's Hospital
Louisville, Kentucky, 40232
Children's Hospital Central California
Madera, California, 93638-8762
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
Yale Cancer Center
New Haven, Connecticut, 06520-8028
Children's Hospital of New Orleans
New Orleans, Louisiana, 70118
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507-1971
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, 32803-1273
Nemours Children's Clinic - Orlando
Orlando, Florida, 32806
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, 95798
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
Saint Jude Midwest Affiliate
Peoria, Illinois, 61603
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239-3098
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, 02903
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298-0037
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229-3993
Rady Children's Hospital - San Diego
San Diego, California, 92123-4282
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, 99220-2555
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
All Children's Hospital
St. Petersburg, Florida, 33701
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Summit, New Jersey, 07901
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, 33607
New York Medical College
Valhalla, New York, 10595
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
Canada7 sites
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1V 4G2
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, S7N 4H4
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Children's and Women's Hospital of British Columbia
Vancouver, British Columbia, V6H 3V4
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Australia1 site
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
About this study
Official title: A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy
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.
Read the 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.
- Being tested
- management of therapy complications
- Keywords
- ototoxicity, unspecified childhood solid tumor, protocol specific
- Medical subject headings
- Ototoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
Undergo hearing tests
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: management of therapy complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria
Measured: Length of study
Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing
Measured: Length of study
Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations)
Measured: Length of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2015
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtotoxicityStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lillian Sung, MD, PhD, Study chair, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458887
- Sponsor's protocol ID
- ACCL05C1
- Other IDs
- COG-ACCL05C1, CDR0000538247
- Status last verified
- Mar 2017
- First submitted
- 9 Apr 2007
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy
- ClinicalTrials.gov ID
- NCT00458887
- Acronym / sponsor ID
- ACCL05C1
- Keywords
- ototoxicity, unspecified childhood solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2007
- Primary completion
- Jan 2015 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary/Correlative (ototoxicity assessment) | – | Procedure: management of therapy complicationsPatients 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients planning to undergo treatment with any cisplatin-containing therapeutic regimen for cancer or planning to enroll on clinical trial ACCL0431
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| management of therapy complicationsAlso: complications of therapy, management ofUndergo hearing tests | Procedure or surgery | Ancillary/Correlative (ototoxicity assessment) |
Primary outcome
Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria
Time frame: Length of study
Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing
Time frame: Length of study
Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations)
Time frame: Length of Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
Related trials for Ototoxicity
Active, not recruiting
Comparative Study of the Quality of Life of Patients Suffering From OTOTOXICITY Due to Chemotherapy Based on Platinum Salts Fitted With a Hearing Aid Compared to Those Not Fitted.
Cancer, Ototoxicity, Drug-Induced
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced
RecruitingPhase 2
Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin
Ototoxicity, Drug-Induced
Not yet recruitingObservational study
OCCUPATIONAL NOISE AND CHEMICAL EXPOSURE EFFECTS ON AUDITORY AND VESTIBULAR FUNCTION
Occupational Noise Exposure
RecruitingPhase 3
A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss
Childhood Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lillian Sung, MD, PhD study chair
The Hospital for Sick Children
81 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ototoxicity and Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Oncology Group at 81 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria (time frame: Length of study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.