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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000105
Receipt No. R000000154
Scientific Title Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)
Date of disclosure of the study information 2005/09/01
Last modified on 2017/07/10

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Basic information
Public title Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)
Acronym Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)
Scientific Title Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)
Scientific Title:Acronym Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes overall survival
Key secondary outcomes relapse-free survival, short-term clinical outcomes, adverse events, the proportion of conversion from LAP to OPEN, the proportion of completion of LAP

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 Surgery:open colectomy
Interventions/Control_2 Surgery:laparoscopic colectomy
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 For inclusion in the study, patients must fulfill the following requirements preoperatively:
(1) histologically proven colorectal carcinoma
(2) tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon
(3) T3 or deeper lesion without involvement of other organs
(4)without multiple lesion other than carcinoma in situ
(5) cancer classified as N0-2 and M0, according to the TNM classification system
(6) tumor size < 8 cm
(7) no bowel obstruction
(8) age 20< and >75 years
(9) sufficient organ function
(10) no history of gastrointestinal surgery
(11) no history of chemotherapy or radiotherapy
(12) provided written informed consent
Key exclusion criteria Exclusion criteria are as follows:
(1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
(2) severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease
(3) pregnant or lactating women
(4) severe mental disease
(5) continuous systemic steroid therapy
Target sample size 818

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seigo Kitano, MD, PhD
Organization Oita University Faculty of Medicine
Division name Gastroenterological Surgery
Zip code
Address 1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Inomata, MD
Organization JCOG0404 Coordinating Office
Division name Oita University Faculty of Medicine
Zip code
Address 1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan
TEL
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 NCT00147134
Org. issuing International ID_1 ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 岩手医科大学(岩手県)
埼玉県立がんセンター(埼玉県)
自治医科大学附属さいたま医療センター(埼玉県)
国立がん研究センター東病院(千葉県)
順天堂浦安病院(千葉県)
国立がん研究センター中央病院(東京都)
杏林大学医学部(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)
北里大学東病院(神奈川県)
北里大学医学部(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)
石川県立中央病院(石川県)
長野市民病院(長野県)
静岡県立静岡がんセンター(静岡県)
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)
国立病院機構大阪医療センター(大阪府)
市立吹田市民病院(大阪府)
広島大学病院(広島県)
国立病院機構四国がんセンター(愛媛県)
久留米大学医学部(福岡県)
大分大学医学部附属病院(大分県)

Other administrative information
Date of disclosure of the study information
2005 Year 09 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/28404155
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 Completed
Date of protocol fixation
2004 Year 09 Month 17 Day
Date of IRB
Anticipated trial start date
2004 Year 11 Month 01 Day
Last follow-up date
2012 Year 10 Month 01 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 09 Month 01 Day
Last modified on
2017 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000154

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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