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
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
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
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
