UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007700 |
|---|---|
| Receipt number | R000009077 |
| Scientific Title | Development of new therapies in primary central nervous system lymphoma |
| Date of disclosure of the study information | 2012/04/09 |
| Last modified on | 2012/04/09 11:58:21 |
* 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
Development of new therapies in primary central nervous system lymphoma
Acronym
Development of new therapies in PCNSL
Scientific Title
Development of new therapies in primary central nervous system lymphoma
Scientific Title:Acronym
Development of new therapies in PCNSL
Region
| Japan |
Condition
Condition
Primary central nervous system lymphoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the clinical impacts of calculating the area under the curve within the serum and cereberospinal fluid or dose intensity of methotrexate
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
overall survival
Key secondary outcomes
response rate and progression-free survival
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Arm A: treated with high-dose MTX + radiotherapy
Interventions/Control_2
Arm B: Radiotheray alone
Interventions/Control_3
Arm C: BSC
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
diagnosis of nonHodgkin lymphoma based on positive stereotactic or surgical biopsy, or CSF cytology; disease confined to CNS, cranial nerves, or eyes; no previous treatment; at least one measurable lesion; age 18–75 years; and adequate bone marrow, renal (creatinine clearance >75 ml min−1), cardiac, and hepatic functions.
Key exclusion criteria
positive for hepatitis B surface antigens, hepatitis C seropositivity, HIV disease or other immunodeficiencies, a Karnofsky performance score (KPS) of less than 50 for reasons not related to PCNSL, other malignant disease, and ongoing pregnancy or lactation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mizuhiko Terasaki |
Organization
Kurume University School of Medicine
Division name
Neurosurgery
Zip code
Address
67 Asahimachi, Kurume
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kurume University School of Medicine
Division name
Neurosurgery
Zip code
Address
TEL
Homepage URL
jintara@med.kurume-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Kurume University
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Kurume University
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 04 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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
| 2012 | Year | 04 | Month | 09 | Day |
Last modified on
| 2012 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009077
