UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050897 |
|---|---|
| Receipt number | R000058005 |
| Scientific Title | Observational study to assess treatment patterns and clinical outcome in advance and/or recurrent endometrial cancer after adjuvant chemotherapy |
| Date of disclosure of the study information | 2023/05/10 |
| Last modified on | 2023/04/20 21:02:03 |
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Basic information
Public title
Observational study to assess treatment patterns and clinical outcome in advance and/or recurrent endometrial cancer after adjuvant chemotherapy
Acronym
PEACH study
Scientific Title
Observational study to assess treatment patterns and clinical outcome in advance and/or recurrent endometrial cancer after adjuvant chemotherapy
Scientific Title:Acronym
PEACH study
Region
| Japan |
Condition
Condition
Endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effectiveness, safety, and treatment status including post-treatment for disease progression of primary treatment after progression or recurrence in patients with endometrial cancer in Japan who have undergone postoperative chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The implementation rates of each drug therapy regimen in actual clinical practice and the progression-free survival periods by cohort for primary treatment after disease progression or recurrence following postoperative chemotherapy.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patients diagnosed histologically or clinically with uterine body cancer (including carcinosarcoma)
2) Patients who have provided written consent for participation in this study
3) Patients who were 18 years of age or older at the time of consent acquisition
4) Patients who underwent postoperative chemotherapy including platinum agents
5) Patients who are planned to receive treatment with combination therapy of TKI+ICI, platinum agent combination therapy (up to 2 agents), or regimens including ICI as primary treatment after disease progression or recurrence following postoperative chemotherapy
6) Patients with measurable lesions by CT or MRI imaging at the time of disease progression or recurrence.
Key exclusion criteria
1) Patients deemed inappropriate as study subjects by the principal investigator and co-investigators
2) Patients who underwent radiation therapy or chemoradiotherapy after surgery (including external radiation therapy and brachytherapy, but palliative radiation therapy for pain relief to bones, brain, or other sites is allowed)
3) Patients who received preoperative treatment
4) Patients who underwent drug therapy with regimens other than cohorts A-C
5) Patients with concomitant active multiple cancers
6) Patients who are participating in clinical research involving interventions (including clinical trials) at the time of case registration.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yoshihito |
| Middle name | |
| Last name | Yokoyama |
Organization
Hirosaki University
Division name
Department of Obstetrics and Gynecology
Zip code
036-8562
Address
5-Zaifu-cho, Hirosaki, Aomori
TEL
0172-33-5111
yokoyama@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiichiro |
| Middle name | |
| Last name | Takahashi |
Organization
JGOG
Division name
JGOG Office
Zip code
162-0825
Address
4th floor Komatsu building 6-22Kagurazaka Shinjuku, Tokyo
TEL
03-5206-1982
Homepage URL
info@jgog.gr.jp
Sponsor or person
Institute
JGOG
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of HirosakiUniversity
Address
5-Zaifu-cho, Hirosaki, Aomori
Tel
0172-33-5111
rinri@hirosaki-u.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
| 2023 | Year | 05 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As this study is an observational study, the treatments given are within the standard of care and are not expected to provide any direct benefit to the participants. However, this study is expected to contribute significantly to the effective and safe drug therapy for uterine corpus cancer in actual clinical practice in our country, which could benefit future patients with uterine corpus cancer. Therefore, the study is considered to have a high social contribution.
Management information
Registered date
| 2023 | Year | 04 | Month | 20 | Day |
Last modified on
| 2023 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058005
