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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028428
Receipt No. 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 2017/07/28

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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
Email 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
Email koshinaga.tsugumichi@nihon-u.ac.jp

Sponsor
Institute Japan Children's Cancer Group (JCCG)
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 03 Day
Last follow-up date
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
2017 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032528

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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