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

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.

Further Study Information

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.

Eligibility Criteria

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 Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

  • National Cancer Institute
Lillian Sung, Study Chair

Trial Sites

U.S.A.

District of Columbia
Washington

Children's National Medical Center

Jeffrey S Dome
Ph: 202-884-2549

Mississippi
Jackson

University of Mississippi Cancer Clinic

Gail C Megason
Ph: 601-815-6700

Missouri
Saint Louis

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Robert J Hayashi
Ph: 800-600-3606
Email: info@siteman.wustl.edu

New Jersey
Summit

Overlook Hospital

Steven L Halpern
Ph: 973-971-5900

Ohio
Cleveland

Cleveland Clinic Taussig Cancer Center

Tanya M Tekautz
Ph: 866-223-8100

Canada

Ontario
Ottawa

Children's Hospital of Eastern Ontario

Jacqueline M Halton
Ph: 613-738-3931

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

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