UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014955 |
|---|---|
| Receipt number | R000017398 |
| Scientific Title | A prospective study for laparoscopic low anterior resection of rectum with lateral pelvic lymph node dissection in patients with advanced lower rectal cancer |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2016/11/16 11:13:39 |
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Basic information
Public title
A prospective study for laparoscopic low anterior resection of rectum with lateral pelvic lymph node dissection in patients with advanced lower rectal cancer
Acronym
laparoscopic lateral pelvic lymph node dissection in patients with advanced lower rectal cancer
Scientific Title
A prospective study for laparoscopic low anterior resection of rectum with lateral pelvic lymph node dissection in patients with advanced lower rectal cancer
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takashi Kinoshita |
Organization
Aichi Prefectural cancer center
Division name
Colorectal Surgery Division
Zip code
Address
1-1 Kanokoden Chikusa-ku, Nagoya, Aichi
TEL
052-762-6111
t-kinoshita@h2.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Wada |
Organization
M's system
Division name
data center
Zip code
Address
4902-1-5-D Hirokute Asahimae-cho Owariasahi Aichi
TEL
0561-51-5590
Homepage URL
marobon@dream.com
Sponsor or person
Institute
Chubu Clinical Oncology Group
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017398
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