Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin
Basic Trial Information
|No phase specified||Natural history/Epidemiology, Supportive care||Closed||1 to 18||NCI, Other||ACCL05C1|
COG-ACCL05C1, CDR0000538247, NCT00458887
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.
- 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
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior cisplatin
Trial Contact Information
Trial Lead Organizations/Sponsors
Children's Oncology Group
- National Cancer Institute
District of Columbia
Children's National Medical Center
Jeffrey S Dome
University of Mississippi Cancer Clinic
Gail C Megason
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Robert J Hayashi
Steven L Halpern
Cleveland Clinic Taussig Cancer Center
Tanya M Tekautz
Children's Hospital of Eastern Ontario
Jacqueline M Halton
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.