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

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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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name