UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027689
Receipt number R000031717
Scientific Title Therapeutic response to enzyme-targeting radiosensitization treatmentusing using hydrogen peroxide and hyaluronic acid
Date of disclosure of the study information 2017/06/08
Last modified on 2019/06/10 11:54:38

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Basic information

Public title

Therapeutic response to enzyme-targeting radiosensitization treatmentusing using hydrogen peroxide and hyaluronic acid

Acronym

Therapeutic response to enzyme-targeting radiosensitization treatmentusing using hydrogen peroxide and hyaluronic acid

Scientific Title

Therapeutic response to enzyme-targeting radiosensitization treatmentusing using hydrogen peroxide and hyaluronic acid

Scientific Title:Acronym

Therapeutic response to enzyme-targeting radiosensitization treatmentusing using hydrogen peroxide and hyaluronic acid

Region

Japan


Condition

Condition

inoperable cancer

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Cardiology
Pneumology Hematology and clinical oncology Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Chest surgery Breast surgery
Obstetrics and Gynecology Pediatrics Ophthalmology
Dermatology Oto-rhino-laryngology Orthopedics
Urology Radiology Oral surgery
Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate therapeutic response to enzyme-targeting radiosensitization treatmentusing using hydrogen peroxide and hyaluronic acid

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Response rate
local control rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Radiotherapy in combination with KORTUC1+2

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)inoperable cancer
2)tumor detected by US or CT
3)Suitable for radiotherapy
4)Written informed consent

Key exclusion criteria

1)Severe complication
2)History of hypersensitivity to hyaluronic acid
3)History of hypersensitivity to H2O2
4)investigator judged ineligible

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hideya
Middle name
Last name Yamazaki

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Radiology

Zip code

602-8566

Address

465 Kajiicho, Kamigyo-ku, Kyoto, Japan

TEL

+81-75-251-5620

Email

yamahi@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Koji
Middle name
Last name Masui

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Radiology

Zip code

602-8566

Address

465 Kajiicho, Kamigyo-ku, Kyoto, 602-8566, Japan

TEL

+81-75-251-5620

Homepage URL


Email

mc0515kj@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine

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

Kyoto Prefectural University of Medicine, Clinical Research Review Board

Address

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto

Tel

+81-75-251-5337

Email

rinri@koto.kpu-m.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

2017 Year 06 Month 08 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 03 Month 24 Day

Date of IRB

2011 Year 09 Month 30 Day

Anticipated trial start date

2017 Year 03 Month 24 Day

Last follow-up date

2018 Year 09 Month 14 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 08 Day

Last modified on

2019 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031717


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name