UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028428 |
|---|---|
| Receipt number | R000032528 |
| Scientific Title | Phase II Clinical Study on Children and Adolescents/Young Adults with Clear Cell Sarcoma of the Kidney |
| Date of disclosure of the study information | 2017/08/10 |
| Last modified on | 2020/01/30 20:15:18 |
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Basic information
Public title
Phase II Clinical Study on Children and Adolescents/Young Adults with Clear Cell Sarcoma of the Kidney
Acronym
Phase II Clinical Study on Children and Adolescents/Young Adults with Clear Cell Sarcoma of the Kidney
Scientific Title
Phase II Clinical Study on Children and Adolescents/Young Adults with Clear Cell Sarcoma of the Kidney
Scientific Title:Acronym
Phase II Clinical Study on Children and Adolescents/Young Adults with Clear Cell Sarcoma of the Kidney
Region
| Japan |
Condition
Condition
Clear cell sarcoma of the kidney (CCSK)
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Stage I/II: to evaluate whether an augmentation with carboplatin allows an omission of abdominal irradiation.
Stage III: to evaluate whether an augmentation with carboplatin and ifosfamide improves a progression-free survival.
Stage IV: to evaluate whether an augmented choemotherapy with carboplatin and ifosfamide be completed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stage I, II, III: progression-free survival.
Stage IV: treatment completion.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Surgery, chemotherapy, irradiation
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Stage I-IV (unilateral)
All patients and/or their legal guardians must sign a written informed consent.
ECOG Performance Status: 3 or less (better).
No prior therapy of anti-cancer drugs and irradiation with the exception of what was written in protocol.
Key exclusion criteria
Relapsed CCSK
Double cancer within 5 years
Organ dysfunction
Positive pregnancy test
Female patients who are lactating
Others written in the protocol
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihisa SAWADA |
Organization
Osaka Women's and Children's Hospital
Division name
Department of Hematology/Oncology
Zip code
Address
840 Murodo, Izumi City, Osaka 594-1101, Japan
TEL
0725-56-1220
asawada@mch.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsugumichi KOSHINAGA |
Organization
Nihon University School of Medicine
Division name
Department of Pediatric Surgery
Zip code
Address
30-1 Ohyaguchikami-cho, Itabashi-ku, Tokyo 173-8610, Japan
TEL
03-3972-8111
Homepage URL
koshinaga.tsugumichi@nihon-u.ac.jp
Sponsor or person
Institute
Japan Children's Cancer Group (JCCG)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
001; 1008
Org. issuing International ID_1
JCCG; Osaka Women's and Children's Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 28 | Day |
Last modified on
| 2020 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032528
