UMIN-CTR Clinical Trial

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
Email	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
Email	masaki@ks.kyorin-u.ac.jp

Sponsor
Institute	Kyorin University, Department of Gastrointestinal Surgery
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024626