UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004957
Receipt number R000005833
Scientific Title Randomized study of Conventional technique vs. No-touch isolation technique (JCOG1006, NTIT study)
Date of disclosure of the study information 2011/01/26
Last modified on 2015/11/13 17:30:49

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Basic information

Public title

Randomized study of Conventional technique vs. No-touch isolation technique (JCOG1006, NTIT study)

Acronym

Randomized controlled study of Conventional technique vs. No-touch isolation technique in patients with colon cancer (JCOG1006, NTIT study)

Scientific Title

Randomized study of Conventional technique vs. No-touch isolation technique (JCOG1006, NTIT study)

Scientific Title:Acronym

Randomized controlled study of Conventional technique vs. No-touch isolation technique in patients with colon cancer (JCOG1006, NTIT study)

Region

Japan


Condition

Condition

colon cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of No-touch isolation technique compared with Conventional technique for patients with potentially curative colon and rectosigmoid cancer with tumor depth of SS, SE, SI, A, or AI..

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Disease-free survival

Key secondary outcomes

Overall survival, Relapse-free survival, liver metastasis-free survival, mode of recurrence, surgical morbidity, adverse events by post-operative chemotherapy, serious adverse events (Grade 4 non-hematological toxicity, early death, treatment-related death), short-term clinical outcomes


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

A: Conventional technique

Interventions/Control_2

B: No-touch isolation technique

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Endoscopic biopsy revealed that the tumor was pathologically proven adenocarcinoma (including muc and sig) or adenosquamous carcinoma.
2. Preoperative endoscopy and radiographical imaging (barium enema or CT) revealed that the tumor was located at Cecum, Ascending, Transverse, Descending, Sigmoid, or Rectosigmoid, and lower border of the tumor was not located at revtum.
3. Preoperative radiographical imaging fulfills all of the following conditions: i) tumor depth of SS, SE, SI, A, or AI, ii) nodal metastasis of N0, N1, or N2, iii) neither H0, P0, nor M0.
4. No multiple colon cancer.
5. Aged 20 to 80 years old.
6. ECOG performance status of 0 or 1.
7. No prior chemotherapy or radiotherapy for any malignancies.
8. Sufficient organ functions.
9. Body mass index of less than 30.
10. No history of intestinal resection, serious obstruction or perforation.
11. No history of familial adenomatous polyposis, ulcerative colitis, or Crohn's disease.
12. Written informed consent.

Key exclusion criteria

1. Simultaneous or metachronous (within 5 years) double cancers.
2. Infectius disease to be treated.
3. Body temperature of 38C or higher.
4. Women during pregnancy or breast-feeding.
5. Psychiatric diseases.
6. Systemic and continuous steroids medication.
7. History of myocardial infarction within 6 months or unstable angina pectoris within 6 months.
8. Severe pulmonary emphysema or pulmonary fibrosis.

Target sample size

850


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasukimi Takii

Organization

Niigata Cancer Center Hospital

Division name

Surgical Division

Zip code


Address

2-15-3, Kawagichi-cho, Chuo-ku, Niigata, 951-8566, JAPAN

TEL

025-266-5111

Email

takii@niigata-cc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasukimi Takii

Organization

JCOG1006 Coordinating Office

Division name

Surgical Division, Niigata Cancer Center Hospital

Zip code


Address

2-15-3, Kawagichi-cho, Chuo-ku, Niigata, 951-8566, JAPAN

TEL

025-266-5111

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

National Cancer Center

Organization

Division

Category of Funding Organization

Other

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

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

札幌厚生病院(北海道)
岩手医科大学(岩手県)
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)
防衛医科大学校(埼玉県)
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)
杏林大学医学部(東京都)
東京医科大学病院(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)
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)
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)
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)
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)
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)
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)
大分大学医学部附属病院(大分県)


Other administrative information

Date of disclosure of the study information

2011 Year 01 Month 26 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

No longer recruiting

Date of protocol fixation

2010 Year 12 Month 24 Day

Date of IRB


Anticipated trial start date

2011 Year 01 Month 26 Day

Last follow-up date

2021 Year 07 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 01 Month 26 Day

Last modified on

2015 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005833


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name