UMIN-ICDS Clinical Trial

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

Endometrial cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

yokoyama@hirosaki-u.ac.jp

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

Email

info@jgog.gr.jp

Institute

JGOG

Institute

Department

Personal name

Organization

Eisai Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

IRB of HirosakiUniversity

Address

5-Zaifu-cho, Hirosaki, Aomori

Tel

0172-33-5111

Email

rinri@hirosaki-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

05

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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/icdr_e/ctr_view.cgi?recptno=R000058005