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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027623
Receipt No. R000031647
Scientific Title Radiotherapy for glioblastoma: Dose escalation trial of IMRT after hyperbaric oxygen therapy
Date of disclosure of the study information 2017/06/03
Last modified on 2017/12/03

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Basic information
Public title Radiotherapy for glioblastoma: Dose escalation trial of IMRT after hyperbaric oxygen therapy
Acronym Dose escalation trial of IMRT after hyperbaric oxygen for glioblastoma
Scientific Title Radiotherapy for glioblastoma: Dose escalation trial of IMRT after hyperbaric oxygen therapy
Scientific Title:Acronym Dose escalation trial of IMRT after hyperbaric oxygen for glioblastoma
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to evaluate the safety of dose-escalation for IMRT boose after hyperbaric oxygen therapy in patients with glioblastoma.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cranial nerve disorder at one, 3, 5, and 7 weeks after the treatments.
CT and MR images, each 3 month after the treatments.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The IMRT boost doses were then continuously
delivered to the GTV plus 5 mm and the surrounding edema. Each IMRT boost session was performed immediately after HBO to achieve radiosensitization.
Group A: GTV+5mm 32Gy/8fr, surrounding edema (16Gy/8fr)
Group B: GTV+5mm 34Gy/8fr, surrounding edema (16Gy/8fr)
Group C: GTV+5mm 36Gy/8fr, surrounding edema (16Gy/8fr)
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
85 years-old >
Gender Male and Female
Key inclusion criteria Pathological diagnosis of glioblastoma
KPS>30
Key exclusion criteria Without brain stem invasion.
Gliomatosis cerebri
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Imada
Organization Tobata Kyoritsu Hospital
Division name Cancer Therapy Center
Zip code
Address 2-5-1 Sawami Tobata-ku, Kitakyushu 804-0093, Japan
TEL 093-871-5421
Email himada60@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Ohguri
Organization University of Occupational and Environmental Health
Division name Radiology
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, Japan
TEL 093-603-1611
Homepage URL
Email ogurieye@med.uoeh-u.ac.jp

Sponsor
Institute Tobata Kyoritsu Hospital
Institute
Department

Funding Source
Organization Tobata Kyoritsu Hospital
Organization
Division
Category of Funding Organization Other
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
2017 Year 06 Month 03 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
2017 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 26 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
2017 Year 06 Month 03 Day
Last modified on
2017 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031647

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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