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Clinical Trials/JPRN-UMIN000026158
JPRN-UMIN000026158
Recruiting
Phase 3

Colonic stent for "Bridge to Surgery" prospective randomized controlled trial comparing treatment with non-stenting surgery in stage II/III obstructive colon cancer - COBRA Trial

PO JORTC0 sites420 target enrollmentFebruary 16, 2017

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
PO JORTC
Enrollment
420
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 16, 2017
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
PO JORTC

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 1\) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval (Carcinoma in situ or other early carcinoma is excluded) 2\) Women who are pregnant, possible to be pregnant or provide breastfeeding 3\) Patient with severe comorbidity of heart, lung, liver and kidney 4\) Patient with cerebrovascular disorder including unstable angina, myocardial infarction, cerebral hemorrhage, cerebral infarction, transient cerebral ischemia or thromboembolism within 6 months before registration 5\) Patient with aortic dissection or aortic aneurysm of more than 5cm in abdomen or more than 6cm in thorax 6\) Patient with diathesis of bleeding or coagulopathy because of decrease in platelets/clotting factor (excluding coagulopathy with preventive antithrombotic agents) 7\) History of hemoptysis with bright red blood more than teaspoon 1/2 cup \[2\.5ml]) within 4 weeks 8\) Patient with infectious disease to need systemic treatment 9\) History of fistula, gastrointestinal perforation, or abscess in the abdominal cavity 10\) Patient with difficulty in participation to clinical trial because of psychosis or mental disorder 11\) Any other cases who are regarded as inadequate for study enrollment by investigators

Outcomes

Primary Outcomes

Not specified

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