UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014488 |
|---|---|
| Receipt number | 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 12:11:57 |
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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
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
keik-okada@hospital.city.osaka.jp
Sponsor or person
Institute
Japanese Pediatric Brain Tumor Consortium
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016691
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
