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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010650
Receipt No. R000012455
Scientific Title phase III Randomized study between retroperitoneal lymphadenectomy with and without caudal external iliac lymph nodes on lymphedema of the lower extremities after surgeries of endometrial cancer (a randomized study by multi-institutes)
Date of disclosure of the study information 2013/06/01
Last modified on 2020/05/10

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Basic information
Public title phase III Randomized study between retroperitoneal lymphadenectomy with and without caudal external iliac lymph nodes on lymphedema of the lower extremities after surgeries of endometrial cancer (a randomized study by multi-institutes)
Acronym P III study on lymphedema of the lower extremities of endometrial cancer
Scientific Title phase III Randomized study between retroperitoneal lymphadenectomy with and without caudal external iliac lymph nodes on lymphedema of the lower extremities after surgeries of endometrial cancer (a randomized study by multi-institutes)
Scientific Title:Acronym P III study on lymphedema of the lower extremities of endometrial cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the benefit of the retroperitoneal lymphadenectomy without caudal external iliac lymph node is expected to decrease the incidence of lymphedema and to alleviate symptoms of the lower extremities after surgeries of endometrial cancer (randomized single-blind trial)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes To compare the cumulative incidences of lymphedema after retroperitoneal lymphadenectomy between with and without caudal external iliac lymph nodes among three years after the surgeries.
Key secondary outcomes To compare the cumulative incidences of lymphedema after retroperitoneal lymphadenectomy between with and without caudal external iliac lymph nodes among three years after the surgeries.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 peritoneal lymphadenectomy with caudal external iliac lymph nodes
Interventions/Control_2 peritoneal lymphadenectomy without caudal external iliac lymph nodes
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) Patients who were diagnosed endometrial cancer by histopathological examination.
2) Patients who will be performed retroperitoneal lymph node dissection.
3) Performance status 0 or 1
1) Patients who were Informed and concented.
Key exclusion criteria 1) Patients with a primary lymphedema or a past histry of lymphedema due to infection
2) Patients who are estimated lymph node metastasis or/and distant metastasis by CT or PET-CT.
3) Patients who were underwent past radiotherapy or chemotherapy.
4) Patients who are regarded as inadequate ones due to other reasons (e.g. severe varix of the lower extremities)
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Sasaki
Organization The Tokyo Jikei University School of Medicine
Division name Kashiwa Hospital, Dept. of OB. & GYN.
Zip code
Address 163-1, Kashiwashita, Kashiwa-shi, Chiba
TEL 04-7164-1111
Email hrssasaki@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Sasaki
Organization The Tokyo Jikei University School of Medicine
Division name Kashiwa Hospital, Dept. of OB. & GYN.
Zip code
Address 163-1, Kashiwashita, Kashiwa-shi, Chiba
TEL 04-7164-1111
Homepage URL
Email hrssasaki@jikei.ac.jp

Sponsor
Institute The development reserarch cancer treatments aiming improvement of QOL
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare Third Research Project on General trategy Against Cancer
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 東京慈恵会医科大学附属柏病院 産婦人科(千葉県)、千葉県がんセンター 婦人科(千葉県)、新潟県立がんセンター新潟病院 婦人科(新潟県)、富山県立中央病院 産婦人科(富山県)、兵庫県立がんセンター 婦人科(兵庫県)、広島市民病院 婦人科(広島県)、独立行政法人国立病院機構四国がんセンター 婦人科(愛媛県)、広島大学病院 産科・婦人科(広島県)、東北大学婦人科学分野(宮城県)、市立札幌病院 産婦人科(北海道)

Other administrative information
Date of disclosure of the study information
2013 Year 06 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 No longer recruiting
Date of protocol fixation
2013 Year 05 Month 05 Day
Date of IRB
2013 Year 02 Month 12 Day
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 08 Month 31 Day
Date trial data considered complete
2021 Year 10 Month 31 Day
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 05 Day
Last modified on
2020 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012455

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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