UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of sentinel lymph node navigation surgery for patients with early stage endometrial cancer
Acronym	Phase II trial of sentinel lymph node navigation surgery for patients with early stage endometrial cancer
Scientific Title	Phase II trial of sentinel lymph node navigation surgery for patients with early stage endometrial cancer
Scientific Title:Acronym	Phase II trial of sentinel lymph node navigation surgery for patients with early stage endometrial cancer
Region	Japan

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

Objectives
Narrative objectives1	We aim to clinically apply sentinel lymph node navigation surgery (SNNS) by validating the validity for minimally invasive surgery using sentinel lymph node biopsy in patients with endometrial cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	incidence of lymphedema
Key secondary outcomes	2-year PFS, OS, recurrence rate, sentinel node detection rate , number of sentinel node, site of sentinel node,, recurrence site, recurrence period, operation time, bleeding volume, adverse event, quality of life

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	Sentinel lymph node navigation surgery
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	1) patients aged 20 years and over 2) patients who obtained written consent from the patient herself 3) patients diagnosed pathologically with G1 or G2 endometrioid canrcinoma by preoperative endometrial biopsy (or endometrial curettage) 4) patients who have no extrauterine lesions, no cervical stromal invasion, and less than half of myometrial invasion by preoperative pelvic MRI 5) patients who have no extrauterine lesions (including regional lymph node metastasis) in chest to pelvic CT. 6) patients agreeing to perform a standard operation procedure including retroperitoneal lymph node dissection in two stages when SN was positive. 7) patient with Performance Status (PS) 0-1. 8) patients with systemic function maintained and undergoing uterine malignant surgery (laparoscopy or laparotomy) under general anesthesia
Key exclusion criteria	1) patients who are considered to be regional lymph node metastasis in preoperative diagnostic imaging 2) patients whith atypical endometrial hyperplasia 3) patients who are thought to be unbearable by standard surgery including retroperitoneal lymph node dissection due to elderly, past history, complications. 4) patients with double cancer 5) patients who have a history of other malignancies. However, excluding cancer patients who do not have cervical carcinoma in situ or who have 5 years or more RFS. 6) patients who have undergone adnexectomy due to ovarian disease etc. 7) patients who have undergone surgery for the retroperitoneal region and irradiation of the pelvic and para-aortic regions due to malignant pelvic tumors 8) patients who are allergic to indocyanine green (ICG) or RI tracer. 9) patients who had radiotherapy to the abdomen / pelvic area 10) patients who had a history of oophorectomy, salpingo-oophorectomy, salpingectomy due to ovarian or fallopian tube disease 11) patients who recognize systemic edema and lower limb edema from preoperative period 12) patients with medical complications with systemic edema 13) Patients who are difficult to follow up at our hospital.
Target sample size	26

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Daisuke Aoki
Organization	Keio University School of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code
Address	35 Shinanomachi Shinjuku-ku Tokyo, JAPAN
TEL	03-3353-1211
Email	aoki@z7.keio.jp

Public contact
1st name of contact person	1st name Middle name Last name Wataru Yamagami
Organization	Keio University School of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code
Address	35 Shinanomachi Shinjuku-ku Tokyo, JAPAN
TEL	03-3353-1211
Homepage URL
Email	gami@z8.keio.jp

Sponsor
Institute	Department of Obstetrics and Gynecology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Self funding
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
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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 13 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	Terminated
Date of protocol fixation	2018 Year 04 Month 12 Day
Date of IRB	2018 Year 04 Month 13 Day
Anticipated trial start date	2018 Year 05 Month 07 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 12 Day
Last modified on	2019 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036744