The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study
Phase 2
Recruiting
- Conditions
- locally advanced colorectal cancer
- Registration Number
- JPRN-UMIN000024323
- Lead Sponsor
- Kansai Medical University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with severe drug allergy (hypersensitivity) 2) Clinical problem infection 3) Liver dysfunction (jaundice) / Severe renal dysfunction 4) Uncontrolled high blood pressure, Diabetes, Hypercalcemia 5) Severe lung disease (Interstitial pneumonia, Pulmonary fibrosis, Advanced emphysema, etc) 6) Patient who need drainage of peritoneal, pleural or pericardial effusion. 7) Brain metastases (Diarrhea a hindrance to daily life in the patient who has a colostomy) 8) Diarrhea (watery stool) 9) Hepatitis B / C virus-positive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate (judged by enhanced CT and MRI on 12 weeks after initiation of chemotherapy)
- Secondary Outcome Measures
Name Time Method Induction rate of curative operation, Overall survival, Relapse free survival. Incidence rate of complication