UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015769 |
|---|---|
| Receipt number | R000018346 |
| Scientific Title | Clinical trial of Novo-TTF-100A for recurrent glioblastoma |
| Date of disclosure of the study information | 2014/11/28 |
| Last modified on | 2014/11/28 10:22:12 |
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Basic information
Public title
Clinical trial of Novo-TTF-100A for recurrent glioblastoma
Acronym
Novo-TTF for recurrent GBM
Scientific Title
Clinical trial of Novo-TTF-100A for recurrent glioblastoma
Scientific Title:Acronym
Novo-TTF for recurrent GBM
Region
| Japan |
Condition
Condition
Recurrent glioblastoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Novo-TTF-100A for recurrent glioblastoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Tumor response
Adverse effects
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
| Device,equipment |
Interventions/Control_1
NovoTTF-100A is composed with transducer array sheets, leads and a connection box.Transducer array sheets should be attached on frontal, occipital and bilateral temporal regions of the patients.The machine should be on almost all day long, at least 18hours a day. Transducer array sheets should be changed every 3 to 4 days. The hair should be shaved when necessary. The treatment should be continued until the progression of the diseases, adverse effects appearance or withdrawal of the patient's consent.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who agreed to participate in this clinincal study in writing after receiving sufficient explanation.
2) Patients with definitive progression of GB on MR, CT or PET scans.
3)The patient should be diagnosed as GB by histology.
4) The patient should be treated by stndard of care such as radiation, chemotherapy with TMZ and/or bevacizumab.
4) KPS is 30% or more.
5) Patients who demonstrate appropriate bone marrow, hepatic and renal functions in laboratory tests within four weeks before the registration.
a) neutrophil count more than 1,500 /mm3
b) Hemoglobin level more than 10.0 g/dL
c) Platelet count more than 10.0 x 104 /micro L
d) Serum creatine level less than 1.4 mg/dL
e) ALT levels less than 100 IU/L
f) AST levels less than 100 IU/L
g) Total birirubin less than1.5 mg/dL
Key exclusion criteria
1) Patients with the infra-tentorial lesions.
2) Patients received with pacemakers or shuntting devices with magnet actions.
3) Pateients with sever systemic complications, necessary for hospitalization.
4) Patients with unhealed scalp wound.
5) Patients with infectious diseses,necessary for antibiotics, so on.
6) Female patients in definitive or possible pregnancy or in breast-feeding.
7) Other patients whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-Ichi Miyatake |
Organization
Osaka Medical College
Division name
Cancer Center
Zip code
Address
Daigaku-Machi, 2-7, Takatsuki, Osaka 569-8686
TEL
072-683-1221
neu070@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin-Ichi Miyatake |
Organization
Osaka Medical College
Division name
Cancer Center
Zip code
Address
Daigaku-Machi, 2-7, Takatsuki, Osaka 569-8686
TEL
072-683-1221
Homepage URL
neu070@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College, Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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 | 11 | Month | 28 | 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 | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 21 | 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 | 11 | Month | 28 | Day |
Last modified on
| 2014 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018346
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