UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032222
Receipt No. R000036744
Scientific Title Phase II trial of sentinel lymph node navigation surgery for patients with early stage endometrial cancer
Date of disclosure of the study information 2018/04/13
Last modified on 2019/04/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.