UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024454 |
|---|---|
| Receipt number | R000028139 |
| Scientific Title | Oncological safety of rectal resection after rectal washout including tumor in patients with rectal cancer who received preoperative Chemoradiotherapy: a prospective clinical study |
| Date of disclosure of the study information | 2016/10/18 |
| Last modified on | 2019/10/21 09:08:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Oncological safety of rectal resection after rectal washout including tumor in patients with rectal cancer who received preoperative Chemoradiotherapy: a prospective clinical study
Acronym
Rectal washout including tumor in patients who received chemoradiotherapy
Scientific Title
Oncological safety of rectal resection after rectal washout including tumor in patients with rectal cancer who received preoperative Chemoradiotherapy: a prospective clinical study
Scientific Title:Acronym
Rectal washout including tumor in patients who received chemoradiotherapy
Region
| Japan |
Condition
Condition
locally advanced rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to verify the oncological safety of sectioning the rectum after rectal washout including the tumor.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cytology of the rectal washout including the primary tumor
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
rectal washout performed with 2000 mL of saline
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
histologically confirmed adenocarcinoma of the middle or lower rectum
clinical Stage II or III
preoperatice chemoradiotherapy
PS (ECOG) 0 or 1
written informed consent
Key exclusion criteria
previous treatment with radiotherapy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sotaro Sadahiro |
Organization
Tokai University
Division name
Department of Surgery
Zip code
Address
143 Shimokasuya Isehara
TEL
0463-93-1121
sadahiro@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kazutake Okada |
Organization
Tokai University
Division name
Department of Surgery
Zip code
Address
143 Shimokasuya Isehara
TEL
0463-93-1121
Homepage URL
kazutake@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Tokai University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 10 | Month | 18 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2004 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 18 | Day |
Last modified on
| 2019 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028139
