UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021353 |
|---|---|
| Receipt number | R000024626 |
| Scientific Title | Implication of intraoperative radiotherapy in rectal cancer surgery with the preservation of voiding and sexual function |
| Date of disclosure of the study information | 2016/03/04 |
| Last modified on | 2019/09/11 09:44:35 |
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Basic information
Public title
Implication of intraoperative radiotherapy in rectal cancer surgery with the preservation of voiding and sexual function
Acronym
Implication of intraoperative radiotherapy in rectal cancer surgery
Scientific Title
Implication of intraoperative radiotherapy in rectal cancer surgery with the preservation of voiding and sexual function
Scientific Title:Acronym
Implication of intraoperative radiotherapy in rectal cancer surgery
Region
| Japan |
Condition
Condition
advanced lower rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the utility of intraoperative radiotherapy for pelvic autonomic nerve preservation in advanced lower rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
5-year local recurrence rate
Key secondary outcomes
5-year overall survival, 5-year disease-free survival, complication rates (small bowel obstruction, pelvic abscess), voiding function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intraoperative radiotherapy (IORT) group:rectal resection(excision),bilateral lateral lymphnode dissection, complete preservation of pelvic autonomic nerves , IORT
radiation frequency: once
cone size: 3.8~5.1cm
radiation energy: 6~12MeV
radiation dose: 18~20Gy
Interventions/Control_2
Control group: rectal resection(excision), bilateral lateral lymphnode dissection, partial preservation of pelvic autonomic nerves(unilateral or S3,S4 sacral nerve preservation)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Histologically proven adenocarcinoma
2 The lower edge of the tumor below the peritoneal reflection
3 The depth of tumor invasion beyond the proper muscle layer or positive mesorectal node metastasis
4 Liver, lung, renal and cardiac functions well preserved
5 No previous history of advanced colon and other organ malignancies
Key exclusion criteria
1 informed consent not obtainable
2 presence of severe complications
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tadahiko |
| Middle name | |
| Last name | Masaki |
Organization
Kyorin University
Division name
Surgery
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
masaki@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadahiko |
| Middle name | |
| Last name | Masaki |
Organization
Kyorin University
Division name
Surgery
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
Homepage URL
masaki@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University, Department of Gastrointestinal Surgery
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
Kyorin Uiversity, Faculty of Medicine
Address
6-20-2, Sinkawa, Mtaka, Tokyo, 181-8611
Tel
0422-47-5511
irb@ks.kyorin-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
杏林大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
79
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2008 | Year | 01 | Month | 03 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2000 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2003 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2004 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 04 | Day |
Last modified on
| 2019 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024626
