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
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/
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
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
