UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Laparoscopic radical hysterectomy for stage IA2, IB1, IIA1 cervical cancer (advanced medical treatment A-36)
Title of the study (Brief title)	LRH-A36
Region	Japan

Condition
Condition	Stage IA2, IB1, IIA1 cervical cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of laparoscopic radical hysterectomy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Disease free survival and overall survival
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	Laparoscopic radiccal hysterectomy
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	70 years-old >
Gender	Female
Key inclusion criteria	Low risk group Good general condition Offical document with informed consent
Key exclusion criteria	A specimen can't be retrieved outside Adjuvant treatment is necessary Severe cimplication Another cancer treated A judgement of the doctor in charge
Target sample size	20

Research contact person
Name of lead principal investigator	Imari Deura
Organization	Tottori university hospital
Division name	Obsterrics and gynecology
Address	Nishi-cho 36-1, Yoago, Tottori
TEL	0859-38-6647
Email	imari@med.tottori-u.ac.jp

Public contact
Name of contact person	Imari Deura
Organization	Tottori university hospital
Division name	Obsterrics and gynecology
Address	Nishi-cho 36-1, Yoago, Tottori
TEL	0859-38-6647
Homepage URL
Email	imari@med.tottori-u.ac.jp

Sponsor
Institute	Tottori university hospital
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)

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	2016 Year 12 Month 18 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 05 Month 09 Day
Anticipated trial start date	2016 Year 05 Month 09 Day
Last follow-up date	2017 Year 04 Month 30 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 04 Month 30 Day
Date analysis concluded	2017 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 18 Day
Last modified on	2017 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029122