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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN C000000034
Receipt No. R000000068
Scientific Title Mesorectal excision with lateral lymph node dissection versus without lateral lymph node dissection for clinical stage II, III lower rectal cancer(JCOG0212)
Date of disclosure of the study information 2005/08/01
Last modified on 2017/04/25

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Basic information
Public title Mesorectal excision with lateral lymph node dissection versus without lateral lymph node dissection for clinical stage II, III lower rectal cancer(JCOG0212)
Acronym Mesorectal excision with lateral lymph node dissection versus without lateral lymph node dissection for clinical stage II, III lower rectal cancer(JCOG0212)
Scientific Title Mesorectal excision with lateral lymph node dissection versus without lateral lymph node dissection for clinical stage II, III lower rectal cancer(JCOG0212)
Scientific Title:Acronym Mesorectal excision with lateral lymph node dissection versus without lateral lymph node dissection for clinical stage II, III lower rectal cancer(JCOG0212)
Region
Japan

Condition
Condition Stage II, III lower rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the oncological effect of international standard operation, mesorectal excision (ME alone) comparing with Japanese standard operation, ME with lateral lymph node dissection for clinical stage II, III lower rectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Relapse-free survival
Key secondary outcomes Overall survival, Local-recurrence-free survival, Incidence of adverse events, Incidence of major adverse events, Operative time, Blood loss, Incidence of sexual and urinary dysfunction

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Mesorectal excision with lateral lymph node dissection
Interventions/Control_2 Mesorectal excision without lateral lymph node dissection
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 Preoperative criteria
1) Histologically confirmed adenocarcinoma
2) Clinical stage II or III
3) Preoperative findings
(i) Main lesion of the tumor is located at the rectum
(ii) Lower tumor margin is below the peritoneal reflection
(iii) No extramesorectal lymph node swelling (Shorter diameter is less than 10 mm)
(iv) No invasion to other organ (s)
4) No multiple colorectal cancers
5) Patient age is more than 20 and less than 75
6) PS: 0, 1
7) No past history of chemotherapy, pelvic surgery or radiation
8) Written informed consent

Operative criteria
9) Mesorectal excision is performed
10) Operative findings
(i) Main lesion of the tumor is located at the rectum
(ii) Lower tumor margin is below the peritoneal reflection
11) R0 after resection
Key exclusion criteria 1) Multiple cancer patients
2) Pregnant patients
3) Psychological disorder
4) Steroid administration
5) Cardiac infarction within six months
6) Severe pulmonary emphysema and pulmonary fibrosis
7) Doctor' s decision for exclusion
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin Fujita, MD
Organization Tochigi Cancer Center
Division name Surgery Division
Zip code
Address 4-9-13, Yonan, Utsunomiya, Tochigi, Japan 320-0834
TEL 025-658-5151
Email sifujita@tcc.pref.tochigi.lg.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin Fujita, MD
Organization JCOG0212 Coordinating Office
Division name Surgery Division, Tochigi Cancer Center
Zip code
Address 4-9-13, Yonan, Utsunomiya, Tochigi, Japan 320-0834
TEL 03-3542-2511
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00190541
Org. issuing International ID_1 ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 札幌厚生病院(北海道)
宮城県立がんセンター(宮城県)
山形県立中央病院(山形県)
栃木県立がんセンター(栃木県)
群馬県立がんセンター(群馬県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学国際医療センター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
東京医科大学病院(東京都)
慶應義塾大学病院(東京都)
東京医科歯科大学(東京都)
東邦大学医療センター大橋病院(東京都)
神奈川県立病院機構神奈川県立がんセンター(神奈川県)
昭和大学横浜市北部病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
済生会横浜市南部病院(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
新潟県厚生連長岡中央綜合病院(新潟県)
富山県立中央病院(富山県)
石川県立中央病院(石川県)
長野市民病院(長野県)
岐阜大学医学部(岐阜県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
藤田保健衛生大学(愛知県)
国立病院機構京都医療センター(京都府)
大阪府立病院機構大阪府立成人病センター(大阪府)
国立病院機構大阪医療センター(大阪府)
大阪府立病院機構大阪府立急性期・総合医療センター(大阪府)
大阪市立総合医療センター(大阪府)
市立堺病院(大阪府)
箕面市立病院(大阪府)
市立吹田市民病院(大阪府)
関西労災病院(兵庫県)
兵庫医科大学(兵庫県)
医療法人薫風会佐野病院(兵庫県)
島根大学医学部(島根県)
岡山済生会総合病院(岡山県)
広島市立広島市民病院(広島県)
県立広島病院(広島県)
広島市立安佐市民病院(広島県)
福山市民病院(広島県)
国立病院機構四国がんセンター(愛媛県)
高知医療センター(高知県)
久留米大学医学部(福岡県)
熊本大学医学部(熊本県)

Other administrative information
Date of disclosure of the study information
2005 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28288057
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
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 Main results already published
Date of protocol fixation
2003 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2003 Year 06 Month 11 Day
Last follow-up date
2017 Year 08 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 08 Month 01 Day
Last modified on
2017 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000068

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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