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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024626


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name