UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027623 |
|---|---|
| Receipt number | 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 | 2023/04/30 09:27:25 |
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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
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
ogurieye@med.uoeh-u.ac.jp
Sponsor or person
Institute
Tobata Kyoritsu Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 15 | Day |
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
| 2023 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031647
