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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

Primary Purpose

Brain Tumor, Central Nervous System Tumor, Childhood Germ Cell Tumor

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
sodium thiosulfate
examination
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Tumor focused on measuring ototoxicity, childhood central nervous system germ cell tumor, childhood extracranial germ cell tumor, childhood extragonadal germ cell tumor, childhood malignant testicular germ cell tumor, childhood malignant ovarian germ cell tumor, childhood teratoma, childhood medulloblastoma, disseminated neuroblastoma, regional neuroblastoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, stage 4S neuroblastoma, localized osteosarcoma, metastatic osteosarcoma, childhood hepatoblastoma, stage I childhood liver cancer, stage II childhood liver cancer, stage III childhood liver cancer, stage IV childhood liver cancer

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Newly diagnosed (previously untreated or currently receiving cancer treatment for the diagnosis that made the patient eligible for this study) with germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy
  • Planning to receive a chemotherapy treatment regimen that includes a cumulative cisplatin dose ≥ 200 mg/m² with individual cisplatin doses to be infused over ≤ 6 hours

  • Enrolled on hearing assessment clinical trial COG-ACCL05C1

    • Normal auditory results

PATIENT CHARACTERISTICS:

  • Karnofsky performance status (PS) 50-100% (for patients > 16 years of age)
  • Lansky PS 50-100% (for patients ≤ 16 years of age)
  • Serum sodium normal
  • Absolute granulocyte count > 1,000/mm³
  • Platelet count > 100,000/mm³
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70mL/min OR serum creatinine between 0.4 and 1.7 mg/dL, based on age and gender
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
  • AST or ALT < 2.5 times ULN for age
  • Not pregnant or nursing
  • Negative pregnancy test (if patient has child-bearing capacity)
  • Fertile patients must use effective contraception
  • No known hypersensitivity to sodium thiosulfate or other thiol agents (e.g., amifostine trihydrate, N-acetylcysteine, MESNA, or captopril)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • No prior platinum-based chemotherapy (cisplatin or carboplatin)

    • Other prior chemotherapy allowed
  • Prior cranial radiotherapy (e.g., for treatment of medulloblastoma) allowed provided normal hearing is documented after completion of radiotherapy and before enrollment and administration of cisplatin chemotherapy

  • At least 6 months since prior hematopoietic stem cell transplantation.

    • No evidence of graft-versus-host disease

  • No concurrent enrollment on another COG clinical trial for treatment of the cancer.

    • Concurrent enrollment on a non-COG clinical trial (e.g., Head start) allowed.
  • Cranial irradiation after the completion of all systemic chemotherapy allowed provided post end-of-treatment audiometry is completed prior to beginning irradiation.
  • Concurrent radiotherapy to extracranial sites allowed.

Sites / Locations

  • UAB Comprehensive Cancer Center
  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Childrens Hospital Los Angeles
  • Southern California Permanente Medical Group
  • Children's Hospital Central California
  • Rady Children's Hospital - San Diego
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Connecticut Children's Medical Center
  • Yale Cancer Center
  • Alfred I. duPont Hospital for Children
  • Children's National Medical Center
  • Lee Cancer Care of Lee Memorial Health System
  • Nemours Children's Clinic
  • University of Miami Sylvester Comprehensive Cancer Center - Miami
  • Florida Hospital Cancer Institute at Florida Hospital Orlando
  • Nemours Children's Clinic - Orlando
  • Nemours Children's Clinic - Pensacola
  • All Children's Hospital
  • St. Joseph's Cancer Institute at St. Joseph's Hospital
  • Cancer Research Center of Hawaii
  • Mountain States Tumor Institute at St. Luke's Regional Medical Center
  • University of Illinois Cancer Center
  • Saint Jude Midwest Affiliate
  • Riley's Children Cancer Center at Riley Hospital for Children
  • Blank Children's Hospital
  • Holden Comprehensive Cancer Center at University of Iowa
  • Kosair Children's Hospital
  • Tulane Cancer Center Office of Clinical Research
  • Children's Hospital of New Orleans
  • National Naval Medical Center
  • C.S. Mott Children's Hospital at University of Michigan Medical Center
  • Hurley Medical Center
  • Helen DeVos Children's Hospital at Spectrum Health
  • Bronson Methodist Hospital
  • Children's Hospitals and Clinics of Minnesota - Minneapolis
  • Masonic Cancer Center at University of Minnesota
  • Mayo Clinic Cancer Center
  • Children's Mercy Hospital
  • Cardinal Glennon Children's Hospital
  • CCOP - Nevada Cancer Research Foundation
  • Hackensack University Medical Center Cancer Center
  • Newark Beth Israel Medical Center
  • University of New Mexico Cancer Center
  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
  • SUNY Upstate Medical University Hospital
  • Presbyterian Cancer Center at Presbyterian Hospital
  • Duke Cancer Institute
  • Wake Forest University Comprehensive Cancer Center
  • Cincinnati Children's Hospital Medical Center
  • Rainbow Babies and Children's Hospital
  • Nationwide Children's Hospital
  • Oklahoma University Cancer Institute
  • Legacy Emanuel Children's Hospital
  • Knight Cancer Institute at Oregon Health and Science University
  • Lehigh Valley Hospital - Muhlenberg
  • Geisinger Cancer Institute at Geisinger Health
  • Children's Hospital of Pittsburgh of UPMC
  • Rhode Island Hospital Comprehensive Cancer Center
  • Sanford Cancer Center at Sanford USD Medical Center
  • East Tennessee Children's Hospital
  • Driscoll Children's Hospital
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • University of Texas Health Science Center at San Antonio
  • Children's Hospital of The King's Daughters
  • Virginia Commonwealth University Massey Cancer Center
  • Providence Cancer Center at Sacred Heart Medical Center
  • St. Vincent Hospital Regional Cancer Center
  • Marshfield Clinic - Marshfield Center
  • Princess Margaret Hospital for Children
  • Children's and Women's Hospital of British Columbia
  • CancerCare Manitoba
  • IWK Health Centre
  • Hospital for Sick Children
  • Hopital Sainte Justine
  • Saskatoon Cancer Centre at the University of Saskatchewan
  • Centre Hospitalier Universitaire de Quebec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

STS Arm (sodium thiosulfate treatment)

Observation Arm (No sodium thiosulfate treatment)

Arm Description

Patients receive sodium thiosulfate IV (dosage 16 g/m2 or 533 mg per kg for patients whose therapeutic protocol administers cisplatin on a per kg basis due to young age or small body) over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy.

Patients do not receive sodium thiosulfate.

Outcomes

Primary Outcome Measures

Incidence of Hearing Loss
Hearing loss defined by comparing hearing sensitivity at follow up evaluation relative to baseline measurements using ASHA criteria.

Secondary Outcome Measures

Change in Hearing Thresholds For Key Frequencies at 500 hz
Mean change in hearing threshold (post-pre) at 500 hz.
Change in Hearing Thresholds For Key Frequencies at 1000 hz
Mean change in hearing threshold (post-pre) at 1000 hz.
Change in Hearing Thresholds For Key Frequencies at 2000 hz
Mean change in hearing threshold (post-pre) at 2000 hz
Change in Hearing Thresholds For Key Frequencies at 4000 hz
Mean change in hearing threshold (post-pre) at 4000 hz.
Change in Hearing Thresholds For Key Frequencies at 8000 hz
Mean change in hearing threshold (post-pre) at 8000 hz.
Event-Free Survival (EFS)
Proportion of patients event free at 4 years following enrollment. See EFS outcome measure description.
Overall Survival (OS)
Proportion of patients alive free at 4 years following enrollment. See OS outcome measure description.
Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT)

Full Information

First Posted
July 15, 2008
Last Updated
July 1, 2021
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00716976
Brief Title
Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy
Official Title
A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 23, 2008 (Actual)
Primary Completion Date
April 9, 2015 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing hearing loss. PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it works in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.
Detailed Description
OBJECTIVES: Primary To 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. Secondary To 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Central Nervous System Tumor, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Liver Cancer, Neuroblastoma, Ototoxicity, Ovarian Cancer, Sarcoma
Keywords
ototoxicity, childhood central nervous system germ cell tumor, childhood extracranial germ cell tumor, childhood extragonadal germ cell tumor, childhood malignant testicular germ cell tumor, childhood malignant ovarian germ cell tumor, childhood teratoma, childhood medulloblastoma, disseminated neuroblastoma, regional neuroblastoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, stage 4S neuroblastoma, localized osteosarcoma, metastatic osteosarcoma, childhood hepatoblastoma, stage I childhood liver cancer, stage II childhood liver cancer, stage III childhood liver cancer, stage IV childhood liver cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STS Arm (sodium thiosulfate treatment)
Arm Type
Experimental
Arm Description
Patients receive sodium thiosulfate IV (dosage 16 g/m2 or 533 mg per kg for patients whose therapeutic protocol administers cisplatin on a per kg basis due to young age or small body) 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 Title
Observation Arm (No sodium thiosulfate treatment)
Arm Type
Experimental
Arm Description
Patients do not receive sodium thiosulfate.
Intervention Type
Drug
Intervention Name(s)
sodium thiosulfate
Other Intervention Name(s)
ADH300001, Disodium Thiosulfate Pentahydrate, Na Thiosulfate, Sodium Hyposulfite, Sodium Thiosulphate, Thiosulfuric Acid, Disodium Salt, Pentahydrate, Versiclear, NSC# 45624, IND#72877
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
examination
Intervention Description
Patients undergo audiological assessments periodically
Primary Outcome Measure Information:
Title
Incidence of Hearing Loss
Description
Hearing loss defined by comparing hearing sensitivity at follow up evaluation relative to baseline measurements using ASHA criteria.
Time Frame
4 weeks after last dose of cisplatin
Secondary Outcome Measure Information:
Title
Change in Hearing Thresholds For Key Frequencies at 500 hz
Description
Mean change in hearing threshold (post-pre) at 500 hz.
Time Frame
4 weeks after last dose of cisplatin
Title
Change in Hearing Thresholds For Key Frequencies at 1000 hz
Description
Mean change in hearing threshold (post-pre) at 1000 hz.
Time Frame
4 weeks after last dose of cisplatin
Title
Change in Hearing Thresholds For Key Frequencies at 2000 hz
Description
Mean change in hearing threshold (post-pre) at 2000 hz
Time Frame
4 weeks after last dose of cisplatin
Title
Change in Hearing Thresholds For Key Frequencies at 4000 hz
Description
Mean change in hearing threshold (post-pre) at 4000 hz.
Time Frame
4 weeks after last dose of cisplatin
Title
Change in Hearing Thresholds For Key Frequencies at 8000 hz
Description
Mean change in hearing threshold (post-pre) at 8000 hz.
Time Frame
4 weeks after last dose of cisplatin
Title
Event-Free Survival (EFS)
Description
Proportion of patients event free at 4 years following enrollment. See EFS outcome measure description.
Time Frame
4 years after enrollment
Title
Overall Survival (OS)
Description
Proportion of patients alive free at 4 years following enrollment. See OS outcome measure description.
Time Frame
4 Years after enrollment
Title
Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT)
Time Frame
4 weeks after the last dose of cisplatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Newly diagnosed (previously untreated or currently receiving cancer treatment for the diagnosis that made the patient eligible for this study) with germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy Planning to receive a chemotherapy treatment regimen that includes a cumulative cisplatin dose ≥ 200 mg/m² with individual cisplatin doses to be infused over ≤ 6 hours Enrolled on hearing assessment clinical trial COG-ACCL05C1 Normal auditory results PATIENT CHARACTERISTICS: Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) Lansky PS 50-100% (for patients ≤ 16 years of age) Serum sodium normal Absolute granulocyte count > 1,000/mm³ Platelet count > 100,000/mm³ Creatinine clearance or radioisotope glomerular filtration rate ≥ 70mL/min OR serum creatinine between 0.4 and 1.7 mg/dL, based on age and gender Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age AST or ALT < 2.5 times ULN for age Not pregnant or nursing Negative pregnancy test (if patient has child-bearing capacity) Fertile patients must use effective contraception No known hypersensitivity to sodium thiosulfate or other thiol agents (e.g., amifostine trihydrate, N-acetylcysteine, MESNA, or captopril) PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior platinum-based chemotherapy (cisplatin or carboplatin) Other prior chemotherapy allowed Prior cranial radiotherapy (e.g., for treatment of medulloblastoma) allowed provided normal hearing is documented after completion of radiotherapy and before enrollment and administration of cisplatin chemotherapy At least 6 months since prior hematopoietic stem cell transplantation. No evidence of graft-versus-host disease No concurrent enrollment on another COG clinical trial for treatment of the cancer. Concurrent enrollment on a non-COG clinical trial (e.g., Head start) allowed. Cranial irradiation after the completion of all systemic chemotherapy allowed provided post end-of-treatment audiometry is completed prior to beginning irradiation. Concurrent radiotherapy to extracranial sites allowed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Freyer, DO, MS
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Study Chair
Facility Information:
Facility Name
UAB Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital Central California
City
Madera
State/Province
California
ZIP/Postal Code
93638-8762
Country
United States
Facility Name
Rady Children's Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123-4282
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Facility Name
Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Lee Cancer Care of Lee Memorial Health System
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Florida Hospital Cancer Institute at Florida Hospital Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803-1273
Country
United States
Facility Name
Nemours Children's Clinic - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Nemours Children's Clinic - Pensacola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
St. Joseph's Cancer Institute at St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Mountain States Tumor Institute at St. Luke's Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712-6297
Country
United States
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7243
Country
United States
Facility Name
Saint Jude Midwest Affiliate
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Riley's Children Cancer Center at Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Blank Children's Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1002
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40232
Country
United States
Facility Name
Tulane Cancer Center Office of Clinical Research
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71315-3198
Country
United States
Facility Name
Children's Hospital of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
National Naval Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889-5600
Country
United States
Facility Name
C.S. Mott Children's Hospital at University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0286
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Helen DeVos Children's Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-5381
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Masonic Cancer Center at University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Cardinal Glennon Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109-2306
Country
United States
Facility Name
Hackensack University Medical Center Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5636
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Presbyterian Cancer Center at Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233-3549
Country
United States
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5000
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Oklahoma University Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Legacy Emanuel Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Knight Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Lehigh Valley Hospital - Muhlenberg
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Geisinger Cancer Institute at Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital Comprehensive Cancer Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Sanford Cancer Center at Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
East Tennessee Children's Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Driscoll Children's Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Children's Hospital of The King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1971
Country
United States
Facility Name
Virginia Commonwealth University Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
Providence Cancer Center at Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220-2555
Country
United States
Facility Name
St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3508
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Children's and Women's Hospital of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3J 3G9
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Saskatoon Cancer Centre at the University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27914822
Citation
Freyer DR, Chen L, Krailo MD, Knight K, Villaluna D, Bliss B, Pollock BH, Ramdas J, Lange B, Van Hoff D, VanSoelen ML, Wiernikowski J, Neuwelt EA, Sung L. Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017 Jan;18(1):63-74. doi: 10.1016/S1470-2045(16)30625-8. Epub 2016 Dec 1. Erratum In: Lancet Oncol. 2017 Jun;18(6):e301.
Results Reference
derived

Learn more about this trial

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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