Randomized study of Conventional technique vs. No-touch isolation technique (JCOG1006, NTIT study)
Phase 3
- Conditions
- colon cancer
- Registration Number
- JPRN-UMIN000004957
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 850
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival
- Secondary Outcome Measures
Name Time Method 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