UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049833
Receipt number R000056754
Scientific Title Effect of Neoadjuvant Chemotherapy on Homologous Recombination Repair Ability in Epithelial Ovarian Cancer
Date of disclosure of the study information 2023/04/01
Last modified on 2023/06/20 18:35:53

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Basic information

Public title

Effect of Chemotherapy on Homologous Recombination Repair Ability

Acronym

JIKEI P-HDR Study

Scientific Title

Effect of Neoadjuvant Chemotherapy on Homologous Recombination Repair Ability in Epithelial Ovarian Cancer

Scientific Title:Acronym

JIKEI P-HDR Study

Region

Japan


Condition

Condition

ovarian carcinoma, tubal carcinoma, peritoneal carcinoma

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The purpose of this study was to investigate the effect of chemotherapy on homologous recombination repair capacity in ovarian, fallopian tube, and peritoneal cancer cases using tumor specimens before and after treatment.

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Percentage change in GIS score with preoperative chemotherapy

Key secondary outcomes

Response rate to chemotherapy before IDS


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

80 years-old >=

Gender

Female

Key inclusion criteria

(1) Patients with histopathologically diagnosed ovarian cancer, fallopian tube cancer, or peritoneal cancer.
(2) Patients diagnosed as advanced stage III or IV by initial surgery (diagnostic laparoscopy or laparotomy), CT or MRI scan, and judged to be unable to undergo primary debulking surgery.
(3) Patients with evaluable lesions
(4) Age between 18 and 80 years old
(5) PS (ECOG) 0 or 1
(6) Patients who have given written informed consent.

Key exclusion criteria

(1) Patients with contraindications to either paclitaxel or carboplatin.
(2) Patients with poorly controlled cardiac disease, renal disease, or diabetes mellitus.
(3) Patients with interstitial pneumonia or pulmonary fibrosis (to be confirmed by CT scan).
(4) Patients with intestinal paralysis or intestinal obstruction that is poorly controlled.
(5) Patients with infectious diseases requiring treatment.
(6) Patients with a history of radiation therapy to the chest or abdomen.
(7) Patients with active multiple cancers (not including intraepithelial cancer).
(viii) Patients with a history of serious drug hypersensitivity.
(9) Patients with symptomatic central nervous system metastasis.
(10) Patients who are pregnant or lactating.
(11) Patients who are currently receiving or have recently received other investigational drugs (including unapproved drugs).
(12) Patients who are judged to be inappropriate to participate in this study by the investigators or co-investigators.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name Nozomu
Middle name
Last name Yanaihara

Organization

The Jikei University

Division name

Obstetrics and Gynecology

Zip code

105-8461

Address

3-25-8 Nishi-Shimbashi, Minato-ku Tokyo 105-8461 Japan

TEL

0334331111

Email

jikei.obgyn.tjmp@jikei.ac.jp


Public contact

Name of contact person

1st name Nozomu
Middle name
Last name Yanaihara

Organization

The Jikei University

Division name

Obstetrics and Gynecology

Zip code

105-8461

Address

3-25-8 Nishi-Shimbashi, Minato-ku Tokyo 105-8461 Japan

TEL

0334331111

Homepage URL


Email

jikei.obgyn.tjmp@jikei.ac.jp


Sponsor or person

Institute

The Jikei University

Institute

Department

Personal name



Funding Source

Organization

Takeda Pharmaceutical 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

Jikei University Clinical Research Review Committee

Address

3-25-8 Nishi-Shimbashi, Minato-ku Tokyo 105-8461 Japan

Tel

03-3433-1111

Email

crb@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



Other administrative information

Date of disclosure of the study information

2023 Year 04 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

Enrolling by invitation

Date of protocol fixation

2022 Year 12 Month 12 Day

Date of IRB

2022 Year 11 Month 17 Day

Anticipated trial start date

2023 Year 04 Month 01 Day

Last follow-up date

2026 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patients with stage III-IV ovarian, fallopian tube, or peritoneal cancer who underwent initial surgery, preoperative chemotherapy including PTX, and subsequent IDS will be included. The homologous recombination repair capacity of tumor specimens at the time of initial surgery and IDS will be calculated as a GIS score using the myChoice diagnostic system, an HRD test.


Management information

Registered date

2022 Year 12 Month 19 Day

Last modified on

2023 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056754


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name