UMIN-CTR Clinical Trial

Basic information
Public title	Safety and feasibility of total laparoscopic radical hysterectomy for patients with cervical cancer
Acronym	Safety and feasibility of total laparoscopic radical hysterectomy
Scientific Title	Safety and feasibility of total laparoscopic radical hysterectomy for patients with cervical cancer
Scientific Title:Acronym	Safety and feasibility of total laparoscopic radical hysterectomy
Region	Japan

Condition
Condition	cervical cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and feasibility of total laparoscopic radical hysterectomy for patients with cervical cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pathological evaluation of curability with resected specimen and the 3-year relapse-free 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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Laparoscopic raadical 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	75 years-old >=
Gender	Female
Key inclusion criteria	1) an age of 20 - 75 years 2) the presence of histologically-proven cervical cancer 3) an International Federation of Gynecology and Obstetrics (FIGO) stage of IA2, IB1, or IIA1 4) Those with adequate organ function 5) Performance status (PS) from 0 to 2 6) Those who have given written informed consent
Key exclusion criteria	1) Patients who have recurrence of cervical cancer 2) Those with previous laparotomy (excluded with appendectomy, cesarean section and surgery for ovarian tumor) or previous radiotherapy of abdomen 3) Those with concomitant active malignancy 4) Those with serious complication 5) Those who are pregnant or suspected to be pregnant 6) Body Mass Index of 30 or greater 7) Those with diagnosis of uterine cervical myoma with ultrasound scanning 8) Patients participating other clinical studies within twelve months. 9) Those who are inadequate to be enrolled in the protocol study by the investigator
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Fujioka
Organization	Ehime University, Graduate School of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code	791-0295
Address	Shitsukawa, Toon, Ehime 791-0295 Japan
TEL	089-960-5379
Email	fujioka@m.ehime-u.ac.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Fujioka
Organization	Ehime University, Graduate School of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code	791-0295
Address	Shitsukawa, Toon, Ehime 791-0295 Japan
TEL	089-960-5379
Homepage URL
Email	fujioka@m.ehime-u.ac.jp

Sponsor
Institute	Ehime University Hospital
Institute
Department

Funding Source
Organization	Department of Obstetrics and Gynecology, Ehime University, Graduate School of Medicine
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	Institutional Review Board, Ehime University Hospital
Address	Shitsukawa, Toon, Ehime
Tel	089-960-5172
Email	rinri@m.ehime-u.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	2016 Year 10 Month 15 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	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 10 Month 22 Day
Date trial data considered complete	2018 Year 10 Month 22 Day
Date analysis concluded	2018 Year 10 Month 22 Day

Other
Other related information

Management information
Registered date	2016 Year 10 Month 15 Day
Last modified on	2020 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028105