UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048457 |
|---|---|
| Receipt number | R000055224 |
| Scientific Title | A multi center, phase 3 study to evaluate safety and efficacy of extensive intraoperative peritoneal lavage, that project to prevent recurrence, in the laparoscopic surgery for advanced colon cancer |
| Date of disclosure of the study information | 2022/07/26 |
| Last modified on | 2022/07/25 22:04:31 |
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Basic information
Public title
A multi center, phase 3 study to evaluate safety and efficacy of extensive intraoperative peritoneal lavage, that project to prevent recurrence, in the laparoscopic surgery for advanced colon cancer
Acronym
SENJYO study
Scientific Title
A multi center, phase 3 study to evaluate safety and efficacy of extensive intraoperative peritoneal lavage, that project to prevent recurrence, in the laparoscopic surgery for advanced colon cancer
Scientific Title:Acronym
SENJYO study
Region
| Japan |
Condition
Condition
locally advanced colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of extensive intraoperative peritoneal lavage in the laparoscopic surgery for advanced colon cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse free survival of pathological T4 and/or N2 cases
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In the treatment group, surgeons perform EIPL (extensive intraoperative peritoneal lavage).
Interventions/Control_2
In the control group, surgeons perform peritonel lavage with less than 1L of saline.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Written consent to participate in the study has been obtained from the patient.
2) Performance Status (ECOG) of either 0 or 1.
3) Patient has operable general condition and organ function.
4) Patients with scheduled laparoscopic surgery for locally advanced colon cancer.
Key exclusion criteria
1) Patients with history of surgery within 4weeks
2) Patients with multiple cancers
Target sample size
2600
Research contact person
Name of lead principal investigator
| 1st name | Mamoru |
| Middle name | |
| Last name | Uemura |
Organization
Osaka University, Graduate School of Medicine
Division name
Departments of Gastroenterological surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3251
muemura@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Takahashi |
Organization
National Hospital Organization Osaka National Hospital
Division name
Department of Surgery
Zip code
540-0006
Address
2-1-14 Hoenzaka, Chuo-ku, Osaka
TEL
06-6942-1331
Homepage URL
takahashi.yusuke.eu@mail.hosp.go.jp
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
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
Osaka University, Graduate School of Medicine
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8290
jim-chiken@hp.crc.med.osaka-u.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
| 2022 | Year | 07 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 01 | 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 | 07 | Month | 25 | Day |
Last modified on
| 2022 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055224
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
