UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study for laparoscopic low anterior resection of rectum with lateral pelvic lymph node dissection in patients with advanced lower rectal cancer
Title of the study (Brief title)	laparoscopic lateral pelvic lymph node dissection in patients with advanced lower rectal cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety and efficacy of laparoscopic lateral lymph node dissection in patients with advanced lower rectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of complication
Key secondary outcomes	3-year local recurrence-free survival,3-year recurrece-free survival,recurrence-free survival,overall survival,operative time,intraoperative bleeding,transition to open surgery,completion of surgery, number of dissected lateral lymph node, voiding dysfunction, hospital days after surgery

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	laparoscopic lateral pelvic lymph node dissection
Interventions/Control_2	lateral lymph node dissection by open surgery
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 confirmed adenocarcinoma (2)recquirement to all of follows by preoperative diagnostic imaging 1.invasion depth is more than T3, or metastasis in N1, N2 lymph node 2.Main lesion of the tumor is located at the rectum 3.Lower tumor margin is below the peritoneal reflection 4.No extramesorectal lymph node swelling (Shorter diameter is less than 10 mm) 5.No invasion to other organ (s) (3) no past history of pelvic radiation (4)without multiple malignancies (5)Patient age is more than 20 and less than 75 (6)PS: 0, 1 (7)adequate organ function (8) Written informed consent
Key exclusion criteria	1.Multiple malignancies to be treated 2.Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. 3.Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer 4.Uncontrolled severe complications(DM, hypertension, diarrhea, et al.) 5.Massive pleural effusion or ascites that required drainage. 6.Patient with symptomatic cardiovascular disease or asymptomatic disease but has been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. 7.With interstitial lung disease or pulmonary fibrosis 8.Continuous systemic steroid therapy (oral or intravenous administration) 9.A history and/or current evidence of significant neurological and/or mental illness 10.Not appropriate for the study at the physician's assessment
Target sample size	22

Research contact person
Name of lead principal investigator	Takashi Kinoshita
Organization	Aichi Prefectural cancer center
Division name	Colorectal Surgery Division
Address	1-1 Kanokoden Chikusa-ku, Nagoya, Aichi
TEL	052-762-6111
Email	t-kinoshita@h2.dion.ne.jp

Public contact
Name of contact person	Tetsuya Wada
Organization	M's system
Division name	data center
Address	4902-1-5-D Hirokute Asahimae-cho Owariasahi Aichi
TEL	0561-51-5590
Homepage URL
Email	marobon@dream.com

Sponsor
Institute	Chubu Clinical Oncology Group
Institute
Department

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)

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	2014 Year 09 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 26 Day
Last modified on	2016 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017398