UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007700
Receipt No. 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

* 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&#8211;75 years; and adequate bone marrow, renal (creatinine clearance >75 ml min&#8722;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
Email

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
Email jintara@med.kurume-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Kurume University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009077

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.