UMIN-CTR Clinical Trial
| Recruitment status | No longer recruiting |
| Unique ID issued by UMIN | UMIN000038707 |
| Receipt No. | 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 (Ver. 4) |
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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 |
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| Condition | ||
| Condition | Colon cancer | |
| Classification by specialty |
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| 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 |
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| Age-upper limit |
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| 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 |
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| 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 |
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| 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 | |
| Institute | Yokohama city university |
| Institute | |
| Department | |
| 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 |
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| 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 |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| 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 |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044130 |
