Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedNatural history/Epidemiology, Supportive careClosed1 to 18NCI, OtherACCL05C1
COG-ACCL05C1, CDR0000538247, NCT00458887

Trial Description


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.

Further Study Information


  • 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.

Eligibility Criteria


  • 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


  • Not specified


  • See Disease Characteristics
  • No prior cisplatin

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

  • National Cancer Institute
Lillian Sung, Study Chair

Trial Sites


District of Columbia

Children's National Medical Center

Jeffrey S Dome
Ph: 202-884-2549


University of Mississippi Cancer Clinic

Gail C Megason
Ph: 601-815-6700

Saint Louis

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Robert J Hayashi
Ph: 800-600-3606

New Jersey

Overlook Hospital

Steven L Halpern
Ph: 973-971-5900


Cleveland Clinic Taussig Cancer Center

Tanya M Tekautz
Ph: 866-223-8100



Children's Hospital of Eastern Ontario

Jacqueline M Halton
Ph: 613-738-3931

Link to the current record.
NLM Identifier NCT00458887 processed this data on February 27, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to