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Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716976
First Posted: July 16, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
Results First Submitted: December 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Brain Tumor
Central Nervous System Tumor
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Liver Cancer
Neuroblastoma
Ototoxicity
Ovarian Cancer
Sarcoma
Interventions: Drug: sodium thiosulfate
Procedure: examination

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
STS Arm (Sodium Thiosulfate Treatment) Sodium thiosulfate treatment.
Observation Arm No sodium thiosulfate treatment.

Participant Flow:   Overall Study
    STS Arm (Sodium Thiosulfate Treatment)   Observation Arm
STARTED   65   66 
COMPLETED   45   57 
NOT COMPLETED   20   9 
Adverse Event                2                0 
Death                1                0 
Physician Decision                2                2 
Withdrawal by Subject                5                1 
Premature discontinuation cisplatin                5                4 
Radiation during protocol                1                0 
Ineligibles                4                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
STS Arm (Sodium Thiosulfate Treatment) Sodium thiosulfate treatment.
Observation Arm No sodium thiosulfate treatment.
Total Total of all reporting groups

Baseline Measures
   STS Arm (Sodium Thiosulfate Treatment)   Observation Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 65   66   131 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      65 100.0%      66 100.0%      131 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.97  (5.93)   8.39  (5.88)   8.68  (5.89) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      27  41.5%      24  36.4%      51  38.9% 
Male      38  58.5%      42  63.6%      80  61.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      19  29.2%      15  22.7%      34  26.0% 
Not Hispanic or Latino      44  67.7%      48  72.7%      92  70.2% 
Unknown or Not Reported      2   3.1%      3   4.5%      5   3.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   1.5%      0   0.0%      1   0.8% 
Asian      1   1.5%      2   3.0%      3   2.3% 
Native Hawaiian or Other Pacific Islander      1   1.5%      1   1.5%      2   1.5% 
Black or African American      7  10.8%      10  15.2%      17  13.0% 
White      44  67.7%      41  62.1%      85  64.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      11  16.9%      12  18.2%      23  17.6% 
Region of Enrollment [1] 
[Units: Participants]
     
Canada   8   4   12 
United States   56   62   118 
[1] 1 patient of unknown origin in STS arm


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Hearing Loss   [ Time Frame: 4 weeks after last dose of cisplatin ]

2.  Secondary:   Change in Hearing Thresholds For Key Frequencies at 500 hz   [ Time Frame: 4 weeks after last dose of cisplatin ]

3.  Secondary:   Change in Hearing Thresholds For Key Frequencies at 1000 hz   [ Time Frame: 4 weeks after last dose of cisplatin ]

4.  Secondary:   Change in Hearing Thresholds For Key Frequencies at 2000 hz   [ Time Frame: 4 weeks after last dose of cisplatin ]

5.  Secondary:   Change in Hearing Thresholds For Key Frequencies at 4000 hz   [ Time Frame: 4 weeks after last dose of cisplatin ]

6.  Secondary:   Change in Hearing Thresholds For Key Frequencies at 8000 hz   [ Time Frame: 4 weeks after last dose of cisplatin ]

7.  Secondary:   Event-Free Survival (EFS)   [ Time Frame: 4 years after enrollment ]

8.  Secondary:   Overall Survival (OS)   [ Time Frame: 4 Years after enrollment ]

9.  Secondary:   Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT)   [ Time Frame: 4 weeks after the last dose of cisplatin ]
Results not yet reported.   Anticipated Reporting Date:   01/2018  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00716976     History of Changes
Other Study ID Numbers: ACCL0431
COG-ACCL0431 ( Other Identifier: Children's Oncology Group )
CDR0000588655 ( Other Identifier: Clinical Trials.gov )
First Submitted: July 15, 2008
First Posted: July 16, 2008
Results First Submitted: December 9, 2016
Results First Posted: June 1, 2017
Last Update Posted: October 12, 2017