UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045224 |
|---|---|
| Receipt number | R000051506 |
| Scientific Title | A non-randomized confirmatory trial of minimum invasive laparoscopic radical hysterectomy (new-Japanese LRH) for patients with early-stage cervical cancer |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2022/09/08 16:15:19 |
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Basic information
Public title
A non-randomized confirmatory trial of minimum invasive laparoscopic radical hysterectomy (new-Japanese LRH) for patients with early-stage cervical cancer
Acronym
A non-randomized confirmatory trial of minimum invasive laparoscopic radical hysterectomy (new-Japanese LRH) for patients with early-stage cervical cancer
Scientific Title
A non-randomized confirmatory trial of minimum invasive laparoscopic radical hysterectomy (new-Japanese LRH) for patients with early-stage cervical cancer
Scientific Title:Acronym
A non-randomized confirmatory trial of minimum invasive laparoscopic radical hysterectomy (new-Japanese LRH) for patients with early-stage cervical cancer
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the non-inferiority of laparoscopic radical hysterectomy (study treatment) to open radical hysterectomy (standard treatment) in terms of 4.5-year recurrence-free survival in patients with clinical stage IA2, IB1/2, or IIA1 cervical cancer.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
4.5-year recurrence-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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
minimum invasive laparoscopic radical hysterectomy (new-Japanese LRH)
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
1.Histopathologically, the primary lesion is confirmed to be cervical cancer
2.The histological type of cervical cancer is one of the following
/Squamous cell carcinoma (Squamous cell carcinoma, keratinizing type, Squamous cell carcinoma, non-keratinizing type)
/Adenocarcinoma (Endocervical adenocarcinoma, usual type, Mucinous carcinoma, intestinal type, Endometrioid carcinoma)
/Adenosquamous carcinoma (Excluding Glassy cell carcinoma).
3.The clinical stage classification of cervical cancer (JSOG 2020, FIGO 2018) is diagnosed as stage 1A2, 1B1/2, or 2A1.
Key exclusion criteria
1.Tumor diameter of cervical cancer exceeding 4cm(Patients will not be eligible for this study if the tumor diameter exceeds 4 cm in any one of the following: measurement by MRI, direct measurement by colposcopy, or measurement by conization specimen)
2.Active multiple cancers (concurrent multiple cancers and heterogeneous multiple cancers with disease-free interval of 5 years or less). However, carcinoma in situ (intraepithelial carcinoma) and intramucosal carcinoma equivalent lesions that are considered curable by local treatment are not included in active multiple cancers).
3.History of radiotherapy treatment to the abdomen or pelvis.
4.Active infection.
5.Fever of 38 degree or higher at the time of registration.
6.Pregnant or breastfeeding.
7.Psychiatric illness/symptoms that would limit compliance the study requirement.
8.Receiving continuous systemic administration of steroids (oral or intravenous).
9.Uncontrolled diabetes mellitus or diabetes mellitus by continuous insulin use.
10.Uncontrolled hypertension
Target sample size
440
Research contact person
Name of lead principal investigator
| 1st name | yoshito |
| Middle name | |
| Last name | terai |
Organization
Kobe university
Division name
obstetrics and gynecology
Zip code
650-0017
Address
7-5-1,Kusunokichou,chuou-ku,kobe city
TEL
078-382-6000
yterai@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobutaka |
| Middle name | |
| Last name | Takahashi |
Organization
shizuoka cancer center
Division name
gynecology
Zip code
411-8777
Address
1007,shimonagakubo,Nagaizumi-chou,suntou-gun,Shizuoka
TEL
055-989-5222
Homepage URL
n.takahashi@scchr.jp
Sponsor or person
Institute
Kobe university
Institute
Department
Personal name
Funding Source
Organization
JGOG (Japanese Gynecologic oncology group)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
touhoku university hospital
Address
1-1,seiryou-chou,aoba-ku,sendai city,Miyagi
Tel
022-717-7000
hosp-ken@grp.tohoku.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
| 2021 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2031 | 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
| 2021 | Year | 08 | Month | 23 | Day |
Last modified on
| 2022 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051506
