UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015001 |
|---|---|
| Receipt number | 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 22:45:15 |
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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
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
endo@nsg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University, Graduate school of medicine, Department of Neurosurgery
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
