UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023870
Receipt number 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 2023/01/13 18:39:18

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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 or person

Institute

Kyoto University

Institute

Department

Personal name



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

2023 Year 01 Month 13 Day



Link to view the page

Value
https://center6.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