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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015001
Receipt No. R000017447
Scientific Title Convection enhanced delivery using ACNU and oral temozolomide therapy to treat recurrent spinal anstrocytoma
Date of disclosure of the study information 2014/09/01
Last modified on 2019/03/05

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Basic information
Public title Convection enhanced delivery using ACNU and oral temozolomide therapy to treat recurrent spinal anstrocytoma
Acronym ACNU CED for recurrent spinal astrocytoma
Scientific Title Convection enhanced delivery using ACNU and oral temozolomide therapy to treat recurrent spinal anstrocytoma
Scientific Title:Acronym ACNU CED for recurrent spinal astrocytoma
Region
Japan

Condition
Condition spinal cord astrocytoma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Examine whether ACNU CED treatment is safe for recurrent spinal astrocytoma
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Determine maximum tolerable concentration of ACNU
Key secondary outcomes Effectiveness, survival rate of 6 months, and overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Catheter implantation (day1)
ACNU (0.25 mg/ml or lower)+ Gd-DOTA(1mM) infusion (day1-2) and TMZ (200mg/m2) p.o. (day1-5)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) For those who suffer recurrent spinal cord astrocytoma and surgical treatment is not indicated. Cases include spinal cord originated tumors and disseminated lesion from intracranial astrocytoma.
2) For those who suffered recurrence after standard treatments including surgical removal, radiotherapy and chemotherapy.
3) For those who did not undertake any of the above mentioned treatment during the previous 4 weeks.
4) For those who have normal laboratory checkup.
5) For those who gave consent to be included in the exam.
Key exclusion criteria 1) For those suffering other cancer
2) For those suffering meningitis or pneumonia
3) Pregnant or Lactating women
4) For those suffering inflammation
5) For those suffering liver dysfunction
6) For those suffering myelo -suppression
7) For those suffering kidney dysfunction
8) For those having bleeding tendency or undertaking anti-coagulation or anti-platelet therapy
9) For those suffering psychiatric disorder
10) For those suffering uncontrolled Diabetes mellius
11) For those who have history of cardiac infarction in the last three months, or suffering angina pectoralis
12) For those having history of Idiopathic pulmonary fibrosis or interstitial pneumonia
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teiji Tominaga
Organization Tohoku University Graduate School of Medicine
Division name Neurosurgery
Zip code
Address 1-1 Seiryo Aoba Sendai Japan
TEL 022-717-7230
Email profTT@nsg.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiki Endo
Organization Tohoku University Graduate School of Medicine
Division name Neurosurgery
Zip code
Address 1-1 Seiryo Aoba Sendai Japan
TEL 022-717-7230
Homepage URL http://www.nsg.med.tohoku.ac.jp/medical/id=55
Email endo@nsg.med.tohoku.ac.jp

Sponsor
Institute Tohoku University, Graduate school of medicine, Department of Neurosurgery
Institute
Department

Funding Source
Organization Tohoku 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
2014 Year 09 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 Enrolling by invitation
Date of protocol fixation
2011 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 09 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 08 Month 30 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017447

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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