UMIN-CTR Clinical Trial

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	Obsterics 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
Institute	Hyogo Cancer Center
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026884