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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018563
Receipt No. R000021481
Scientific Title A study of the efficacy of preoperative chemotherapy and radiation therapy for rectal cancer
Date of disclosure of the study information 2015/08/06
Last modified on 2019/03/01

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Basic information
Public title A study of the efficacy of preoperative chemotherapy and radiation therapy for rectal cancer
Acronym A study of the efficacy of preoperative chemotherapy and radiation therapy for rectal cancer
Scientific Title A study of the efficacy of preoperative chemotherapy and radiation therapy for rectal cancer
Scientific Title:Acronym A study of the efficacy of preoperative chemotherapy and radiation therapy for rectal cancer
Region
Japan

Condition
Condition rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of preoperative chemoradiotherapy for rectal cancer in retrospective study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3-year local control rate
Key secondary outcomes (1)3-year over-all survival rate
(2)Complete chemoradiotherapy rate
(3)Postoperative complications rate

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Diagnosis of rectal cancer in preoperative pathology (tissue type does not matter).
(2) Case of rectal cancer after CRT in a preoperative diagnosis of A ,AI or Dukes C are diagnosed (Japanese Classification of Colorectal Carcinoma the 7th edition) and the cases that made the CRT.
(3) presence or absence of distant metastases does not matter
(4) presence or absence of primary tumor resection does not matter
Key exclusion criteria (1)Preoperative diagnosis of rectal cancer in M or MP and N0 Stage I (Japanese Classification of Colorectal Carcinoma the 7th edition)
(2)Patients who principal investigator has determined to be inappropriate as a subject
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Yamamoto
Organization Tokyo Women's Medical University
Division name Department of Surgery, Institute of Gastroenterology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL +81-3-3353-8111
Email yamamoto.ige@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryosuke Nakagawa
Organization Tokyo Women's Medical University
Division name Department of Surgery, Institute of Gastroenterology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL +81-3-3353-8111
Homepage URL
Email nakagawa.ryosuke@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University Hospital
Institute
Department

Funding Source
Organization None
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
2015 Year 08 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5452334/
Number of participants that the trial has enrolled
Results The completion rate of CRT was high at 94% (n?=?29/31). The downstaging rate of CRT was 61% (n?=?19/31). The pathological complete response rate was 6.5% (n?=?2/31). Significant differences were observed in the 3-year local recurrence rate between the two groups (P?<?0.05).
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 12 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We evaluate the efficacy of preoperative chemo-radiation therapy for the lower rectal cancer in our department between 2009 and 2013. We examine treatment results (patient factors, pathology factors, surgery factors, prognosis)
This study is a retrospective cohort study to evaluate the rate of 3 years local control.

Management information
Registered date
2015 Year 08 Month 06 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021481

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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