PhaseIII trial of neoadjuvant chemotherapy using CAPEOX with optional local treatment for locally advanced rectal cancer
Phase 2
- Conditions
- ocally advanced rectal cancer
- Registration Number
- JPRN-UMIN000032254
- Lead Sponsor
- Yokohama City University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 440
Inclusion Criteria
Not provided
Exclusion Criteria
1) Synchronous or metachronous (within 5 years)malignancies other than carcinoma in situ or mucosal carcinoma 2) Bowel obstruction 3) Uncontrollable diabetes mellitus (HbA1c>=8.0) 4) Unstable ungina pectoris 5) Liver cirrhosis,Liver failure 6) Interstitial pneumonia 7) Pregnant or possibly pregnant women 8) Past history of using 5-FU, oxaliplatin based chemotherapy 9) Past history of radiotherapy 10) Other conditions judged ineligible by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 5-year relapse free survival
- Secondary Outcome Measures
Name Time Method CRM positive rate, CRT rate, LLND rate, R0 rate, morbidity rate, response rate of neoadjuvant chemotherapy/chemoradiotherapy and completion rate, 5-year local recurrence rate, 5-year overall survival