UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048925 |
|---|---|
| Receipt number | R000055568 |
| Scientific Title | A Phase2 Trial of Total Parietal Peritonectomy in Primary Debulking Surgery for Advanced Ovarian Neoplasm |
| Date of disclosure of the study information | 2022/09/20 |
| Last modified on | 2022/10/10 08:06:53 |
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Basic information
Public title
A study on efficacy and safety of total peritoneal resection in surgical treatment of advanced ovarian cancer
Acronym
TPP study
Scientific Title
A Phase2 Trial of Total Parietal Peritonectomy in Primary Debulking Surgery for Advanced Ovarian Neoplasm
Scientific Title:Acronym
TPP Phase 2 Trial
Region
| Japan |
Condition
Condition
ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients with stage IIIB-IIIC ovarian cancer with extensive peritoneal dissemination are eligible. We will evaluate the efficacy of total parietal peritonectomy (TPP) in primary debulking surgery (PDS) when complete surgery (no macroscopically residual disease) is performed with multiple organ resection to determine whether TPP improves prognosis . At the same time, we will evaluate the safety of TPP in terms of complications.
If this Phase II study shows that TPP may be effective and the safety profile is acceptable, we will proceed to phase III study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
2-year RFS rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Total Parietal Peritonectomy
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
* Primary diagnosis of ovarian cancer FIGO stage IIIB-IIIC
* Macroscopic complete resection is possible with PDS based on preoperative examination, staging laparoscopy, and intraoperative findings during PDS
* Histology is diagnosed as High Grade Serous Carcinoma or Endometrioid Carcinoma by tissue biopsy during staging laparoscopy
* Patients who have given their signed and written informed consent
* Age: 18 - 70 years
* Good performance status (ECOG 0/1)
Key exclusion criteria
* Borderline tumors
* There are suspicious lymph nodes (bulky nodes) in preoperative examination and intraoperative findings and systematic retroperitoneal lymphadenectomy is required
* Secondary invasive neoplasms in the last 5 years (However, it is permissible if the possibility of recurrence within 2 years after registration is sufficiently low)
* Neoadjuvant chemotherapy
* Any significant medical reasons, age or performance status that will not
allow to perform the study procedures
* Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Aikou |
| Middle name | |
| Last name | Okamoto |
Organization
The Jikei University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
105-8461
Address
3-19-18 Nishishinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
aikou@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Yokosu |
Organization
The Jikei University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
105-8461
Address
3-19-18 Nishishinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
Homepage URL
kouta_yokosu@yahoo.co.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
National Cancer Center Hospital East Institutional Review Board
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, Japan
Tel
04-7133-1111
irst@ml.res.ncc.go.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
| 2022 | Year | 09 | Month | 20 | 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 | 08 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 13 | Day |
Last modified on
| 2022 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055568
