UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the efficacy of preoperative chemotherapy and radiation therapy for rectal cancer
Title of the study (Brief title)	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	Masakazu Yamamoto
Organization	Tokyo Women's Medical University
Division name	Department of Surgery, Institute of Gastroenterology
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	Ryosuke Nakagawa
Organization	Tokyo Women's Medical University
Division name	Department of Surgery, Institute of Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5452334/
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).
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