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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014488
Receipt No. R000016691
Scientific Title Pilot study of multimodality treatment based on a new risk stratification in patients with medulloblastoma
Date of disclosure of the study information 2014/08/01
Last modified on 2015/09/10

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Basic information
Public title Pilot study of multimodality treatment based on a new risk stratification in patients with medulloblastoma
Acronym Pilot study based on a new risk stratification for medulloblastoma
Scientific Title Pilot study of multimodality treatment based on a new risk stratification in patients with medulloblastoma
Scientific Title:Acronym Pilot study based on a new risk stratification for medulloblastoma
Region
Japan

Condition
Condition Medulloblastoma
Classification by specialty
Pediatrics Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Risk stratification is based on disseminated disease, extent of resection, molecular genetics, histologic factors and age of the patient. Patients receive multimodality treatment of different intensities for each risk.
Determine whether some parts of multimodality treatment are safe: maintenance therapy, intrathecal chemotherapy, and high-dose chemotherapy consisting of busulfan/melphalan.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of adverse events
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 Operation, multiagent chemotherapy (vincristine, cisplatin, cyclophosphamide, etoposide, intrathecal methotrexate), and radiotherapy (18-24 Gy to the craniospinal axis plus boost at the tumor bed to 50-51.2 Gy).
And high-dose chemotherapy(busulfan, melphalan) for high-risk patients.
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
0 years-old <=
Age-upper limit
25 years-old >
Gender Male and Female
Key inclusion criteria 1. Diagnosis of 1 of the following, medulloblastoma, supratentorial primitive neuroectodermal tumor, pineoblastoma.
2. Has undergone operation within the past 42 days.
3. No prior radiotherapy or chemotherapy.
4. PS score: 0-3.
5. WBC >2000/mm3, ANC >1000/mm3, Platelet count >100000/mm3
6. ALT <100 IU/L, T-Bil <1.5 mg/dl, serum creatinine < upper limit of normal.
Key exclusion criteria 1. Has double cancer.
2. Has cardiac disease for which treatment is necessary.
3. Pregnant or nursing.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Hara
Organization Osaka City General Hospital
Division name Pediatric Hematology/Oncology
Zip code
Address 2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka
TEL +81-6-6929-1221
Email j-hara@hospital.city.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Okada
Organization Osaka City General Hospital
Division name Pediatric Hematology/Oncology
Zip code
Address 2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka
TEL +81-6-6929-1221
Homepage URL
Email keik-okada@hospital.city.osaka.jp

Sponsor
Institute Japanese Pediatric Brain Tumor Consortium
Institute
Department

Funding Source
Organization The Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 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
2014 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 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
2014 Year 07 Month 06 Day
Last modified on
2015 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016691

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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