|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 Lead Organizations/Sponsors
Children's Oncology GroupNational Cancer Institute
|Lillian Sung||Study Chair|
|District of Columbia|
|Children's National Medical Center|
|Jeffrey S Dome||Ph: 202-884-2549|
|University of Chicago Cancer Research Center|
|Susan L Cohn||Ph: 773-834-7424|
|Western Michigan University School of Medicine Clinics|
|Jeffrey S Lobel||Ph: 800-227-2345|
|University of Mississippi Cancer Clinic|
|Gail C Megason||Ph: 601-815-6700|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis|
|Robert J Hayashi||Ph: 800-600-3606|
|Steven L Halpern||Ph: 973-971-5900|
|Cleveland Clinic Taussig Cancer Center|
|Tanya M Tekautz||Ph: 866-223-8100|
|Legacy Emanuel Hospital and Health Center and Children's Hospital|
|Janice F Olson||Ph: 503-413-8199|
|Children's Hospital of Eastern Ontario|
|Jacqueline M Halton||Ph: 613-738-3931|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00458887
ClinicalTrials.gov processed this data on October 17, 2013
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