UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010650 |
|---|---|
| Receipt number | 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 | 2022/10/14 10:51:13 |
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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
| Obstetrics 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 | Hiroshi |
| Middle name | |
| Last name | Sasaki |
Organization
The Tokyo Jikei University School of Medicine
Division name
Kashiwa Hospital, Dept. of OB. & GYN.
Zip code
277-8567
Address
163-1, Kashiwashita, Kashiwa-shi, Chiba
TEL
04-7164-1111
hrssasaki@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sasaki |
Organization
The Tokyo Jikei University School of Medicine
Division name
Kashiwa Hospital, Dept. of OB. & GYN.
Zip code
277-8567
Address
163-1, Kashiwashita, Kashiwa-shi, Chiba
TEL
04-7164-1111
Homepage URL
hrssasaki@jikei.ac.jp
Sponsor or person
Institute
The development reserarch cancer treatments aiming improvement of QOL
Institute
Department
Personal name
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
The Tokyo Jikei University School of Medicine
Address
163-1, Kashiwashita, Kashiwa-shi, Chiba
Tel
04-7164-1111
hrssasaki@jikei.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
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
non
Publication of results
Unpublished
Result
URL related to results and publications
non
Number of participants that the trial has enrolled
150
Results
non
Results date posted
| 2022 | Year | 10 | Month | 14 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Analysis delayed.
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
| 2022 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012455
