UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051539 |
|---|---|
| Receipt number | R000058806 |
| Scientific Title | Cytoreductive Surgery plus Hyperthermic Intraperitoneal Chemotherapy versus R0 Resection for Resectable Colorectal Cancer with Peritoneal Metastases with Low Peritoneal Cancer Index Score: A Collaborative Observational Study from Korea and Japan |
| Date of disclosure of the study information | 2023/07/06 |
| Last modified on | 2023/07/06 18:00:13 |
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Basic information
Public title
Cytoreductive Surgery plus Hyperthermic Intraperitoneal Chemotherapy versus R0 Resection for Resectable Colorectal Cancer with Peritoneal Metastases with Low Peritoneal Cancer Index Score: A Collaborative Observational Study from Korea and Japan
Acronym
CRS + HIPEC vs R0 resection alone
Scientific Title
Cytoreductive Surgery plus Hyperthermic Intraperitoneal Chemotherapy versus R0 Resection for Resectable Colorectal Cancer with Peritoneal Metastases with Low Peritoneal Cancer Index Score: A Collaborative Observational Study from Korea and Japan
Scientific Title:Acronym
CRS + HIPEC vs R0 resection alone
Region
| Japan | Asia(except Japan) |
Condition
Condition
Colorectal Cancer with Peritoneal Metastases
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aimed to compare the long-term oncological outcomes and clinical manifestations of patients with CPM and PCI scores 6 or less who underwent R0 resection in Japan with those who underwent CRS plus HIPEC in Korea.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse-free survival (RFS), which was defined as the time from surgery for CPM to the first peritoneal or distant relapse or death from any cause.
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
| 17 | years-old | <= |
Age-upper limit
| 82 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with a PCI score of 6 or less and CC-0, who underwent surgery between July 2014 and December 2021 for both synchronous and metachronous CPM, were included in this study.
Key exclusion criteria
Patients with appendiceal cancer were excluded.
Target sample size
166
Research contact person
Name of lead principal investigator
| 1st name | Eun Jung |
| Middle name | |
| Last name | Park |
Organization
Gangnam Severance Hospital
Division name
Division of Colon and Rectal Surgery
Zip code
06273
Address
211 Eonju-ro, Gangnam-gu, Seoul, Korea
TEL
+82-2-2019-3897
camp79@yuhs.ac
Public contact
Name of contact person
| 1st name | Daichi |
| Middle name | |
| Last name | Kitaguchi |
Organization
National Cancer Center Hospital East
Division name
Department of Colorectal Surgery
Zip code
2778577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
+81-4-7133-1111
Homepage URL
dkitaguc@east.ncc.go.jp
Sponsor or person
Institute
Yonsei University College of Medicine
Institute
Department
Personal name
Funding Source
Organization
A new faculty research seed money grant of Yonsei University College of Medicine for 2022 (2022-32-0061)
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Research Ethics Review Board of the National Cancer Center Hospital
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
Tel
+81-3-3542-2511
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
3-2022-0483
Org. issuing International ID_1
Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
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 | 07 | Month | 06 | 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
166
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
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The primary outcome was relapse-free survival (RFS), which was defined as the time from surgery for CPM to the first peritoneal or distant relapse or death from any cause. Secondary outcomes were OS (defined as the interval between surgery for CPM and death from any cause), peritoneal RFS (PRFS; the interval between surgery for CPM and the first peritoneal relapse or death from any cause), and postoperative outcomes. The differences in RFS, OS, and PRFS between the CRS + HIPEC and R0 resection groups were evaluated.
Management information
Registered date
| 2023 | Year | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058806
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