UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041745 |
|---|---|
| Receipt number | R000047645 |
| Scientific Title | Observational and retrospective study on the effect and safety of Tumor Treating Fields for newly diagnosed glioblastoma |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2024/03/13 09:48:42 |
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Basic information
Public title
Observational and retrospective study on the effect and safety of Tumor Treating Fields for newly diagnosed glioblastoma
Acronym
Observational and retrospective study on the effect and safety of Tumor Treating Fields for newly diagnosed glioblastoma
Scientific Title
Observational and retrospective study on the effect and safety of Tumor Treating Fields for newly diagnosed glioblastoma
Scientific Title:Acronym
Observational and retrospective study on the effect and safety of Tumor Treating Fields for newly diagnosed glioblastoma
Region
| Japan |
Condition
Condition
Glioblastoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect and safety of Tumor Treating Fields for newly diagnosed glioblastoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival rate
Key secondary outcomes
Overall survival rate of the subgroup classified by extent of resection, KPS, age, and implantation of BCNU wafers
Adverse effect
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Newly diagnosed glioblastoma
2) Age 18y.o.- 80 y.o.
3) Male and female
4) KPS 70-100
5) Patient who received concomitant RT/Temozolomide
6) include the patients who was treated by carmustine wafers and photodynamic therapy
Key exclusion criteria
1) Lesion was mainly located at cerebellum or brainstem
2) Patient with leptomeningeal dissemination
3) Patient with progressive disease during concomitant RT/Temozolomide
4) Patient who received bevacizumab
Target sample size
460
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kanamori |
Organization
Tohoku University Hospital
Division name
Department of Neurosurgery
Zip code
980-8574
Address
1-1 Seiryou-chou, Aoba-ku, Sendai, Japan
TEL
0227177230
mkanamori@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Kanamori |
Organization
Tohoku University Hospital
Division name
Department of Neurosurgery
Zip code
980-8574
Address
1-1 Seiryou-chou, Aoba-ku, Sendai, Japan
TEL
0227177230
Homepage URL
mkanamori@med.tohoku.ac.jp
Sponsor or person
Institute
Self funding
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Tohoku University Graduate School of Medicine
Address
1-1 Seiryo-cho, Aoba-ku,
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
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
| 2020 | Year | 10 | 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
0
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 19 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 19 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 22 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 25 | Day |
Other
Other related information
Through a retrospective study, we will clarify the efficacy and safety of tumor treating fields for newly diagnosed glioblastoma in Japan. If the number of cases did not reach the target of 460 cases, we planned to prospectively enroll and analyze cases as an observational study. However, the number of patients exceed the 460 cases from retrospective data collection, we decided not to collect prospectively the data of patients.
Consider the impact on survival and recurrence by multivariate analysis instead of analysis by propensity score matching method due to the large number of events.
Management information
Registered date
| 2020 | Year | 09 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047645
