UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032222 |
|---|---|
| Receipt number | 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 07:27:28 |
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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
| Obstetrics 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
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
gami@z8.keio.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology,
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036744
