UMIN-CTR Clinical Trial

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
Email	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
Email	mkanamori@med.tohoku.ac.jp

Sponsor
Institute	Self funding
Institute
Department

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
Email	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
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	2020 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2025 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study was conducted to elucidate the effects and safety of Tumor Treating Fields for newly diagnosed glioblastoma in Japan with observational and retrospective study. With propensity matching method, we select the patients treated by radiation, temozolomide, and Tumor Treating Fields or by only radiation and temozolomide with same backgrounds. The overall survival rate of these groups are compared.

Management information
Registered date	2020 Year 09 Month 09 Day
Last modified on	2020 Year 09 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047645

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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