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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032672
Receipt No. R000037255
Scientific Title One-week hypofractionated radiotherapy in elderly and frail patients with newly diagnosed glioblastoma
Date of disclosure of the study information 2018/08/01
Last modified on 2019/01/04

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Basic information
Public title One-week hypofractionated radiotherapy in elderly and frail patients with newly diagnosed glioblastoma
Acronym One-week hypofractionated radiotherapy in elderly and frail patients with newly diagnosed glioblastoma
Scientific Title One-week hypofractionated radiotherapy in elderly and frail patients with newly diagnosed glioblastoma
Scientific Title:Acronym One-week hypofractionated radiotherapy in elderly and frail patients with newly diagnosed glioblastoma
Region
Japan

Condition
Condition Glioblastoma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of one-week hypofractionated radiotherapy in elderly and frail patients with newly diagnosed glioblastoma
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Overall survival, Response rate, Adverse event, Severe adverse event, Cognitive function, Quality of life

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Radiotherapy (Focal 25Gy/5fraction)
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Newly diagnosed and histologically confirmed glioblastoma (GBM, WHO GradeIV).
2. Registration should be completed >=7days and <=21days after resection or biopsy. The protcol treatment should start>=7days and <=28days after resection or biopsy.
3. Age >=65 years, <=75 years with performance status 3. Age >=76 years with performance status 2 or 3.
4. Regardless of use of GLIADEL Wafer
5. Patient has not received prior chemotherapy or radiotherapy.
6. Written informed consent.
Key exclusion criteria 1. Infectious disease requiring systemic treatment.
2. Other active malignancy.
3. Dissemination.
4. Attending physician has determined unsuitable to participate in the study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yohei Miyake
Organization Yokohama city university
Division name Department of Neurosurgery
Zip code
Address 3-9, fukuura, kanazawa-ku, yokohama, kanagawa
TEL 045-787-2800
Email ymiyaken@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yohei Miyake
Organization Yokohama city university
Division name Department of Neurosurgery
Zip code
Address 3-9, fukuura, kanazawa-ku, yokohama, kanagawa
TEL 045-787-2800
Homepage URL
Email ymiyaken@gmail.com

Sponsor
Institute Yokohama city university
Institute
Department

Funding Source
Organization Yokohama city 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
Email

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
2018 Year 08 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 Terminated
Date of protocol fixation
2018 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 15 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
2018 Year 05 Month 22 Day
Last modified on
2019 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037255

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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