UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038707 |
|---|---|
| Receipt number | R000044130 |
| Scientific Title | multicenter study for treatment of colon cancer |
| Date of disclosure of the study information | 2019/11/30 |
| Last modified on | 2021/05/31 21:52:35 |
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Basic information
Public title
multicenter study for treatment of colon cancer
Acronym
multicenter study for treatment of colon cancer
Scientific Title
multicenter study for treatment of colon cancer
Scientific Title:Acronym
multicenter study for treatment of colon cancer
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the 5-year overall survival of laparoscopic surgery for colon cancer, and compared to open surgery for colon cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year overall survival rate of laparoscopic and open surgery for colon cancer
Key secondary outcomes
1.To investigate the comparison of 5-year disease free survival rate between laparoscopic surgery and open surgery.
2.To investigate the safety and effectivity for preoperative treatment (adverse event, completion rate, response rate, disease-free survival time, overall survival time, et al.)
3. To investigate the operative procedures, postoperative complication rates and the risk factors for postoperative complications.
4.To investigate the postoperative incisional hernia.
5. To investigate the effect of postoperative adjuvant chemotherapy.
6. To investigate the recurrence site and treatment after surgery.
7. To investigate the impact of postoperative complications for long-term outcomes.
8. To investigate the outcomes for the cases with clinical T4b(invasion to adjacent organs).
9. To investigate the outcomes for the cases with distant metastases (clinical Stage IV).
10.To investigate the surgical outcomes for the obesity cases(BMI, SFA, VFA)
11. To investigate the outcomes of laparoscopic surgery for elderly cases.
12. To investigate the outcomes for the cases with paraaortic lymph node dissection.
13. To investigate the outcomes for the cases with comorbidity(cardiac disease, pulmonary disease, antiplatelet therapy, anticoagulant therapy).
14. To investigate the effectiveness of lymph node dissection using lymph node dissection index.
15. Subgroup analysis: To analyze the above outcomes by tumor locations, pathological stages et al.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the cases who had pathologically adenocarcinoma, and were undergone surgery.
Key exclusion criteria
judgement not to register suitably.
Target sample size
12000
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Yokohama city university medical center
Division name
Center of gastroenterology
Zip code
2320024
Address
4-57 Urafune, Minami-ku, Yokohama
TEL
0452615656
jun0926@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Tominaga |
Organization
Yokohama city university
Division name
Y-NEXT
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
0457872800
Homepage URL
ynext@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university
Institute
Department
Personal name
Funding Source
Organization
no funding source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama city university
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
0457872800
t196056a@yokohama-cu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
315
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
| 1992 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 1992 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.To investigate the comparison of 5-year disease free survival rate between laparoscopic surgery and open surgery.
2.To investigate the safety and effectivity for preoperative treatment (adverse event, completion rate, response rate, disease-free survival time, overall survival time, et al.)
3. To investigate the operative procedures, postoperative complication rates and the risk factors for postoperative complications.
4.To investigate the postoperative incisional hernia.
5. To investigate the effect of postoperative adjuvant chemotherapy.
6. To investigate the recurrence site and treatment after surgery.
7. To investigate the impact of postoperative complications for long-term outcomes.
8. To investigate the outcomes for the cases with clinical T4b(invasion to adjacent organs).
9. To investigate the outcomes for the cases with distant metastases (clinical Stage IV).
10.To investigate the surgical outcomes for the obesity cases(BMI, SFA, VFA)
11. To investigate the outcomes of laparoscopic surgery for elderly cases.
12. To investigate the outcomes for the cases with paraaortic lymph node dissection.
13. To investigate the outcomes for the cases with comorbidity(cardiac disease, pulmonary disease, antiplatelet therapy, anticoagulant therapy).
14. To investigate the effectiveness of lymph node dissection using lymph node dissection index.
15. Subgroup analysis: To analyze the above outcomes by tumor locations, pathological stages et al.
Management information
Registered date
| 2019 | Year | 11 | Month | 28 | Day |
Last modified on
| 2021 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044130
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