UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046209 |
|---|---|
| Receipt number | R000052672 |
| Scientific Title | Analysis of survival impact of lymphadenectomy in endometrial cancer patients received adjuvant chemotherapy at intermediate/high risk of progression. |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2023/12/20 16:09:59 |
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Basic information
Public title
Analysis of survival impact of lymphadenectomy in endometrial cancer patients received adjuvant chemotherapy at intermediate/high risk of progression.
Acronym
JGOG2043-A4
Scientific Title
Analysis of survival impact of lymphadenectomy in endometrial cancer patients received adjuvant chemotherapy at intermediate/high risk of progression.
Scientific Title:Acronym
JGOG2043-A4
Region
| Japan |
Condition
Condition
Endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the survival effect of lymphadenectomy in intermediate/high risk endometrial cancer patient who were enrolled in the JGOG2043 trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse-free survival
Key secondary outcomes
Overall survival
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
Intermediate/high risk endometrial cancer patient who were enrolled in the JGOG2043 trial
Key exclusion criteria
Patient without registration of the number of resected lymph node
Target sample size
780
Research contact person
Name of lead principal investigator
| 1st name | Hidemichi |
| Middle name | |
| Last name | Watari |
Organization
Hokkaido University Graduate School of Medicine and Faculty of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
0608638
Address
Kita15, Nishi7, Kita-Ku, Sapporo Hokkaido
TEL
011-706-5941
watarih@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Konno |
| Middle name | |
| Last name | Yosuke |
Organization
Hokkaido University Hospital
Division name
Department of Gynecology
Zip code
060-8648
Address
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido
TEL
011-716-1161
Homepage URL
konsuke013@gmail.com
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Japanese Gynecologic Oncology Group
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
Hokkaido University Hospital Institutiona Review Board
Address
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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 | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Preparing for paper submission
Publication of results
Unpublished
Result
URL related to results and publications
Preparing for paper submission
Number of participants that the trial has enrolled
788
Results
Although it was difficult to assess the therapeutic significance of PAN dissection in the JGOG 2043 cohort, thorough PLN dissection was shown to improve pelvic control and OS.
Results date posted
| 2023 | Year | 12 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients at high risk of uterine cancer recurrence enrolled in the JGOG2043 trial and receiving adjuvant therapy.
Cases with residual disease or missing data were excluded.
Pelvic lymph node dissection only was performed in 250 cases, and para-aortic lymphadenectomy in 402 cases.
Participant flow
Among 788 patients registered, firstly, we excluded the patients who had the missing data of the resected PLN number (n=80), those with any residual tumors (n=25), and those with missing data on LVSI (n=31). The remaining 652 cases were subjected to this post-hoc analysis.
Adverse events
none
Outcome measures
Comparison of disease-free survival and overall survival between pelvic lymph node removal only and para-aortic lymph node removal groups
Comparison of site of recurrence, disease-free survival, and overall survival of patients who had 20or more pelvic lymph nodes removed and those who had fewer than 20 pelvic lymph nodes removed
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective subset analysis
Management information
Registered date
| 2021 | Year | 11 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052672
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| Registered date | File name |
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