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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000041745 |
Receipt No. | 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 | 2020/09/09 |
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 |
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Condition | ||
Condition | Glioblastoma | |
Classification by specialty |
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 460 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tohoku University Hospital | ||||||
Division name | Department of Neurosurgery | ||||||
Zip code | 980-8574 | ||||||
Address | 1-1 Seiryou-chou, Aoba-ku, Sendai, Japan | ||||||
TEL | 0227177230 | ||||||
mkanamori@med.tohoku.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Anticipated trial start date |
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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 |
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Last modified on |
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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 |