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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023870
Receipt No. R000027485
Scientific Title A clinical study to evaluate the feasibility and dose delivery accuracy of Volumetric-modulated Dynamic WaveArc therapy
Date of disclosure of the study information 2016/10/01
Last modified on 2018/03/06

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Basic information
Public title A clinical study to evaluate the feasibility and dose delivery accuracy of Volumetric-modulated Dynamic WaveArc therapy
Acronym VMDWAT feasibility study
Scientific Title A clinical study to evaluate the feasibility and dose delivery accuracy of Volumetric-modulated Dynamic WaveArc therapy
Scientific Title:Acronym VMDWAT feasibility study
Region
Japan

Condition
Condition Prostate cancer, brain tumor (skull-based tumor)
Classification by specialty
Urology Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility and dose delivery accuracy of volumetric-modulated Dynamic WaveArc therapy
Basic objectives2 Others
Basic objectives -Others Feasibility study
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The ratio of the patients who completed the treatment course
Key secondary outcomes Incidence of acute adverse events,
Incidence of severe acute adverse events

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Volumetric-modulated Dynamic WaveArc therapy (VMDWAT) is delivered to patients with prostate cancers and brain tumors (skull-based tumors).
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Clinically diagnosed as prostate cancer or brain tumor (skull-based tumor)
2) ECOG-PS(performance status) = 0,1,2
Key exclusion criteria 1) With severe coexisting diseases such as collagen disease, heart disease, respiratory disease and liver disease.
2) Psychotic disease
3) History of irradiation to the area where VMDWAT is considered to be delivered
4) Dose distribution of VMDWAT is inferior to that of conventional radiotherapy
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Mizowaki
Organization Kyoto University Graduate School of Medicine
Division name Department of Radiation Oncology and Image-applied Therapy
Zip code
Address 54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3762
Email mizo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Mizowaki
Organization Kyoto University Graduate School of Medicine
Division name Department of Radiation Oncology and Image-applied Therapy
Zip code
Address 54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3762
Homepage URL
Email mizo@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
15 cases were registered. DWA treatment was completed in all cases. No grade 2 or higher adverse event was observed. Physical quality assuarances revealed that radiation was very accurately delivered in all the cases.
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 Main results already published
Date of protocol fixation
2016 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2017 Year 09 Month 24 Day
Date of closure to data entry
2017 Year 09 Month 30 Day
Date trial data considered complete
2017 Year 09 Month 30 Day
Date analysis concluded
2017 Year 10 Month 31 Day

Other
Other related information Radiat Oncol. 2018 Feb 14;13(1):27. doi: 10.1186/s13014-018-0972-7.

Management information
Registered date
2016 Year 08 Month 31 Day
Last modified on
2018 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027485

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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