UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023449
Receipt number R000026884
Scientific Title The prospective study on the safety of metalic markers for radiotherapy of gynecological cancer
Date of disclosure of the study information 2016/08/04
Last modified on 2019/11/01 16:20:31

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Basic information

Public title

The prospective study on the safety of metalic markers for radiotherapy of gynecological cancer

Acronym

The safety of metal markers for radiotherapy of gynecological cancer

Scientific Title

The prospective study on the safety of metalic markers for radiotherapy of gynecological cancer

Scientific Title:Acronym

The safety of metal markers for radiotherapy of gynecological cancer

Region

Japan


Condition

Condition

Cervical cancer, Endometrial cancer, Vaginal cancer, Vulvar cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

No metalic fiducial markers covered by insurance exist in Japan. In other institutions in Japan, handmade titanium markers, or gold markers which were approved by insurance for other carcinomas were often used. The purpose was to investigate the safety of metalic markers.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sever complications within 3 months after the implantation of metalic markers.

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Implantation of metalic markers into tumors or the tissue close to 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

Female

Key inclusion criteria

Cervical cancer, Uterine endometrial cancer, Vaginal cancer, Vulvar cancer;
PS 0-2;
benefit of marker implantation
Written informed consent.

Key exclusion criteria

Coagulation disorder;
Severe coexisting disease;
Pregnancy, possible pregnancy.

Target sample size

75


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name SHUHEI SEKII

Organization

Hyogo Cancer Center

Division name

Department of Radiation Oncology

Zip code


Address

70, Kitaoji-cho 13, Akashi-shi, Hyogo, Japan

TEL

078-929-1151

Email

ssekii@hp.pref.hyogo.jp


Public contact

Name of contact person

1st name
Middle name
Last name SHUHEI SEKII

Organization

Hyogo Cancer Center

Division name

Department of Radiation Oncology

Zip code


Address

70, Kitaoji-cho 13, Akashi-shi, Hyogo, Japan

TEL

078-929-1151

Homepage URL


Email

ssekii@hp.pref.hyogo.jp


Sponsor or person

Institute

Hyogo Cancer Center

Institute

Department

Personal name



Funding Source

Organization

None

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


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

兵庫がんセンター/Hyogo Cancer Center


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 04 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

Main results already published

Date of protocol fixation

2016 Year 07 Month 26 Day

Date of IRB

2016 Year 07 Month 28 Day

Anticipated trial start date

2016 Year 07 Month 28 Day

Last follow-up date

2019 Year 11 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 08 Month 02 Day

Last modified on

2019 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026884


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name