Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy
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ClinicalTrials.gov Identifier: NCT00716976 |
Recruitment Status :
Completed
First Posted : July 16, 2008
Results First Posted : June 1, 2017
Last Update Posted : November 9, 2023
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Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
- Study Details
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Study Type | Interventional |
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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 |
Enrollment | 131 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | STS Arm (Sodium Thiosulfate Treatment) | Observation Arm |
---|---|---|
Arm/Group Description | Sodium thiosulfate treatment. | No sodium thiosulfate treatment. |
Period Title: Overall Study | ||
Started | 65 | 66 |
Completed | 45 | 57 |
Not Completed | 20 | 9 |
Reason Not Completed | ||
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
Arm/Group Title | STS Arm (Sodium Thiosulfate Treatment) | Observation Arm | Total | |
---|---|---|---|---|
Arm/Group Description | Sodium thiosulfate treatment. | No sodium thiosulfate treatment. | Total of all reporting groups | |
Overall Number of Baseline Participants | 65 | 66 | 131 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 65 participants | 66 participants | 131 participants | |
<=18 years |
65 100.0%
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66 100.0%
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131 100.0%
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Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 65 participants | 66 participants | 131 participants | |
8.97 (5.93) | 8.39 (5.88) | 8.68 (5.89) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 65 participants | 66 participants | 131 participants | |
Female |
27 41.5%
|
24 36.4%
|
51 38.9%
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|
Male |
38 58.5%
|
42 63.6%
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80 61.1%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 65 participants | 66 participants | 131 participants | |
Hispanic or Latino |
19 29.2%
|
15 22.7%
|
34 26.0%
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Not Hispanic or Latino |
44 67.7%
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48 72.7%
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92 70.2%
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Unknown or Not Reported |
2 3.1%
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3 4.5%
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5 3.8%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 65 participants | 66 participants | 131 participants | |
American Indian or Alaska Native |
1 1.5%
|
0 0.0%
|
1 0.8%
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|
Asian |
1 1.5%
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2 3.0%
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3 2.3%
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|
Native Hawaiian or Other Pacific Islander |
1 1.5%
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1 1.5%
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2 1.5%
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Black or African American |
7 10.8%
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10 15.2%
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17 13.0%
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White |
44 67.7%
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41 62.1%
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85 64.9%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
11 16.9%
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12 18.2%
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23 17.6%
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Region of Enrollment
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 65 participants | 66 participants | 131 participants |
Canada | 8 | 4 | 12 | |
United States | 56 | 62 | 118 | |
[1]
Measure Description: 1 patient of unknown origin in STS arm
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Outcome Measures
Adverse Events
Limitations and Caveats
Data was and never will be collected for Outcome Measure #9, Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT).
More Information
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.
Must obtain prior Sponsor approval.
Results Point of Contact
Name/Title: | Results Reporting Coordinator |
Organization: | Children's Oncology Group |
Phone: | 626-447-0064 |
EMail: | 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 |
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: | November 9, 2023 |