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Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00458887
First received: April 9, 2007
Last updated: October 18, 2012
Last verified: September 2012
History of Changes

April 9, 2007
October 18, 2012
May 2007
December 2013   (final data collection date for primary outcome measure)
  • Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria
  • Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing
  • Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations)
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Complete list of historical versions of study NCT00458887 on ClinicalTrials.gov Archive Site
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Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin
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.

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.
Observational
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  • Ototoxicity
  • Unspecified Childhood Solid Tumor, Protocol Specific
Procedure: management of therapy complications
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
327
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December 2013   (final data collection date for primary outcome measure)

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
Both
1 Year to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT00458887
CDR0000538247, COG-ACCL05C1
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Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Lillian Sung, MD, PhD The Hospital for Sick Children
National Cancer Institute (NCI)
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP