UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter observational study on treatment results for rectal cancer
Acronym	Multicenter observational study on treatment results for rectal cancer
Scientific Title	Multicenter observational study on treatment results for rectal cancer
Scientific Title:Acronym	Multicenter observational study on treatment results for rectal cancer
Region	Japan

Condition
Condition	Rectal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the 5-year overall survival rate of laparoscopic surgery for rectal cancer at our hospital and related facilities with open surgery and to examine its validity in a retrospective, prospective, multicenter observational study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Five-year overall survival rate of laparoscopic surgery group and open surgery group
Key secondary outcomes	Comparative study of 5-year recurrence-free survival rate between laparoscopic surgery group and open surgery group Safety and efficacy of preoperative treatment cases (adverse events, treatment completion rate, response rate, recurrence-free survival, overall survival, etc.) Study on surgical procedure, postoperative complication rate, and risk factors for postoperative complications Study on postoperative abdominal scar hernia Whether postoperative adjuvant chemotherapy is performed and its details Study on recurrence site and post-recurrence treatment Effects of postoperative complications on long-term outcome Treatment results of cases invading other organs Treatment results of a case with distant metastasis (cStage IV) Treatment results in obese cases (BMI, VFA, SFA) Treatment results of laparoscopic surgery in the elderly Treatment results of para-aortic lymph node dissection Treatment results for patients with coexisting diseases (heart disease, lung disease, oral antiplatelet drug etc.) Examination of the depth of primary lesion and the diagnostic ability of lateral lymph node metastasis by preoperative MRI Short-term and long-term results of lateral dissection Study on lymph node dissection effect using dissection index Subgroup analysis Analyze the above evaluation items for each subgroup such as tumor occupancy site and pStage

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Rectal cancer patient
Key exclusion criteria	Patients who are judged as inappropriate by the doctor
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Watanabe
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Zip code	232-0024
Address	4-57, Urafune-cho, Minami-ku
TEL	0452615656
Email	nabe-jun@comet.ocn.ne.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Watanabe
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Zip code	232-0024
Address	4-57, Urafune-cho, Minami-ku
TEL	0452615656
Homepage URL
Email	nabe-jun@comet.ocn.ne.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Self funding
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	the institutional review board for studies in humans
Address	3-9 Fukuura, Kanazawa-ku
Tel	+81457872650
Email	nabe-jun@comet.ocn.ne.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

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 14 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	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 10 Day
Date of IRB	2019 Year 06 Month 26 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 05 Month 14 Day
Last modified on	2020 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046110