UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000105
Receipt number 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 13:27:30

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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 or person

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name



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

Value
https://center6.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