Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy : A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children

OBJECTIVES:PrimaryTo compare the efficacy of sodium thiosulfate vs observation in preventing hearing loss in young patients receiving cisplatin for the treatment of newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.SecondaryTo compare the mean change in hearing thresholds for key frequencies in these patients.To compare the incidences of cisplatin-related grade 3 and 4 nephrotoxicity and grade 3 and 4 cytopenia in these patients.To compare the event-free survival and overall survival of these patients.To evaluate the association of two key gene mutations (TPMT and COMT) with the development of cisplatin-induced hearing loss in these patients.OUTLINE: This is a multicenter study. Patients are stratified according to prior cranial radiation (yes vs no), age (< 5 years vs ≥ 5 years) and duration of cisplatin infusion (< 2 hours vs ≥ 2 hours). Patients are randomized to 1 of 2 arms.Arm I (sodium thiosulfate): Patients receive sodium thiosulfate IV over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy.Arm II (observation): Patients do not receive sodium thiosulfate.Patients undergo audiological assessment at baseline, prior to each course of cisplatin, and then at 4 weeks and 1 year after the last course of cisplatin or other cancer treatment. Some patients may undergo saliva collection for DNA studies.After completion of study, patients are followed periodically for 10 years..

Medienart:	Klinische Studie

Erscheinungsjahr:	2023
Erschienen:	2023

Enthalten in:	ClinicalTrials.gov - (2023) vom: 09. Nov. Zur Gesamtaufnahme - year:2023

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Central Nervous System Neoplasms Hepatoblastoma Liver Neoplasms Medulloblastoma Neoplasms Neoplasms, Germ Cell and Embryonal Nervous System Neoplasms Neuroblastoma Osteosarcoma Ototoxicity Phase: Phase 3 Recruitment Status: Completed Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: July 16, 2008, Last downloaded: ClinicalTrials.gov processed this data on November 15, 2023, Last updated: November 15, 2023

Study ID:	NCT00716976 ACCL0431 COG-ACCL0431 CDR0000588655
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PPN (Katalog-ID):	CTG000583456