JPRN-UMIN000009715
Recruiting
Phase 3
A randomized controlled trial comparing laparoscopic surgery with open surgery in palliative resection of primary tumor in incurable Stage IV colorectal cancer (JCOG1107) - Encore Trial: Trial of <en>doscopic palliative <co>lorectal <re>section for symptomatic unresectable colorectal cancer (JCOG1107)
Japan Clinical Oncology Group (JCOG)0 sites194 target enrollmentJanuary 7, 2013
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- nresectable Stage IV colorectal cancer and a synchronous symptomatic primary tumor
- Sponsor
- Japan Clinical Oncology Group (JCOG)
- Enrollment
- 194
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma 2\) Infectious disease to be treated 3\) HBs antigen positive 4\) Body temparature \>\= 38c 5\) Women during pregnancy, possible pregnancy or breast\-feeding 6\) Severe mental disease 7\) Currently treated with systemic steroids 8\) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema 9\) Uncontrollable diabetes mellitus or routine administration of insulin 10\) Uncontrolled hypertension, defined as systolic \>\= 150 and/or diastolic \>\= 100 mmHg 11\) New York Heart Association class III /IV cardiac disease or congestive heart failure that would take medication in order to prevent lethal ventricular arrhythmias 12\) Gastrointestinal fistula, perforation, or abscess within 6 months 13\) Unstable angina pectoris, previous myocardial infarction, or arterial thrombotic event within 6 months 14\) Abdominal aortic aneurysm (\>\= 5cm), thoracic aortic aneurysm (\>\= 6cm), or aortic dissection 15\) Congenital hemorrhagic diathesis, coagulation disorder, or significant episodes of acute bleeding of grade 3 or more according to CTCAE ver.4\.0 within the past 28 days 16\) Episodes of hemoptysis within 28 days
Outcomes
Primary Outcomes
Not specified
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