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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name