UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)
Title of the study (Brief title)	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	Seigo Kitano, MD, PhD
Organization	Oita University Faculty of Medicine
Division name	Gastroenterological Surgery
Address	1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan
TEL
Email

Public contact
Name of contact person	Masafumi Inomata, MD
Organization	JCOG0404 Coordinating Office
Division name	Oita University Faculty of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 09 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/28404155
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
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