UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009048 |
|---|---|
| Receipt number | R000003584 |
| Scientific Title | A multi-centre open label randomised phase III trial of the efficacy of Sodium Thiosulphate in reducing ototoxicity in patients receiving Cisplatin chemotherapy for standard risk hepatoblastoma |
| Date of disclosure of the study information | 2012/10/05 |
| Last modified on | 2021/06/04 21:29:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A multi-centre open label randomised phase III trial of the efficacy of Sodium Thiosulphate in reducing ototoxicity in patients receiving Cisplatin chemotherapy for standard risk hepatoblastoma
Acronym
SIOPEL6
Scientific Title
A multi-centre open label randomised phase III trial of the efficacy of Sodium Thiosulphate in reducing ototoxicity in patients receiving Cisplatin chemotherapy for standard risk hepatoblastoma
Scientific Title:Acronym
SIOPEL6
Region
| Japan | Asia(except Japan) | Australia |
| Europe |
Condition
Condition
Standard risk hepatoblastoma
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To assess the efficacy of STS to reduce the hearing impairment caused by Cisplatin chemotherapy for standard risk hepatoblastoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Rate of Brock grade 1 hearing loss determined after end of trial treatment or at an age of at least 3.5 years, whichever is later.
Key secondary outcomes
Response to preoperative chemotherapy
Complete resection
Complete remission
Event free survival (EFS)
Overall survival (OS)
Toxicity as graded by CTCAE v 3.0
Long-term renal clearance
Feasibility of central audiology review
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cisplatin alone
Interventions/Control_2
Cisplatin + Sodium Thiosulphate
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | months-old | <= |
Age-upper limit
| 227 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Histologically confirmed newly diagnosed hepatoblastoma
Standard risk hepatoblastoma
Centre/country willing and able to organise audiometry at the minimum required quality
Ability to comply with requirements for submission of material for central revieved
For females of child-bearing potential, a negative pregnancy test prior to study treatment is required.
Any patient who is of reproductive age should agree to use adequate contraception for the duration of the trial.
Key exclusion criteria
High risk hepatoblastoma
Hepatocellular carcinoma
Treatment starting more than 15 days from written biopsy report
Abnormal renal function
Any previous chemotherapy
Recurrent disease
Previous hypersensitivity to STS
Patient unable to follow the protocol for any reason
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | Eiso |
| Middle name | |
| Last name | Hiyama |
Organization
Hiroshima University
Division name
Natural Center for Basic Research and Development
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5416
eiso@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Kurihara |
Organization
Hiroshima University Hospital
Division name
Pediatric Surgery
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5217
Homepage URL
http://home.hiroshima-u.ac.jp/jpltstudy/index.html
akarata@hiroshima-u.ac.jp
Sponsor or person
Institute
Japanese study group for pediatric liver tumors
Institute
Department
Personal name
Funding Source
Organization
Japanese study group for pediatric liver tumors
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Health, Labour and Welfare Ministry, Japan
Name of secondary funder(s)
Children's Cancer Association of Japan
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
Tel
082-257-5596
hugcp@hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2007-002402-21
Org. issuing International ID_1
EUDRACT(European clinical trial database)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
広島大学病院（広島県）, 兵庫県立こども病院（兵庫県）、茨城県立こども病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
http://home.hiroshima-u.ac.jp/eiso/
Publication of results
Published
Result
URL related to results and publications
https://www.nejm.org/doi/10.1056/NEJMoa1801109
Number of participants that the trial has enrolled
129
Results
The number of objected cases was enrolled.
109 cases were originally enrolled.
The primary objective, hearing loss was measured using audiologic evaluations. The proportion of children in the CIS+STS arm with hearing loss (20 children [35.1%]) was approximately one-half compared with the CIS Alone arm (35 children [67.3%]). The risk of having hearing loss was statistically significantly lower in the CIS+STS arm compared with the CIS Alone arm (relative risk: 0.521, 95% CI: 0.349, 0.778; p<0.001),
Results date posted
| 2021 | Year | 06 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 06 | Month | 21 | Day |
Baseline Characteristics
A total of 129 children were registered
Participant flow
114 children were randomized in the study (61 patients in the CIS+STS arm and 53 patients in the CIS Alone arm) (
Adverse events
In the CIS+STS and CIS Alone arms, the PTs of infection (7 patients [13.2%] and 5 patients [8.9%], respectively) and pyrexia (5 patients [9.4%] and 3 patients [5.4%], respectively) were among the most common SAEs. The other most common SAEs (reported by 2 patients) in the CIS+STS arm were neutrophil count decreased (6 patients [11.3%]) and procedural complication (2 patients [3.8%]). No other SAEs were experienced by more than 1 patient in either arm.
Outcome measures
Brock Grade hearing loss was measured using audiologic evaluations
the CIS+STS arm compared with the CIS Alone arm (relative risk: 0.521, 95% CI: 0.349, 0.778; p<0.001),
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2009 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2011 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 05 | Day |
Last modified on
| 2021 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003584
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/06/04 | SIOPEL-6-para-RE.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
