A Phase II Study of Short-course Radiotherapy Preoperatively followed by Capecitabine and Oxaliplatin (XELOX) for cT3 Node-positive Lower Rectal Cancer
Not Applicable
- Conditions
- ow rectal cancer
- Registration Number
- JPRN-UMIN000023361
- Lead Sponsor
- Cancer Institute Hospital of Japanese Foundation for Cancer Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Not provided
Exclusion Criteria
1. cT4 or cN2. 2. CRM less than 1mm. 3. Administration contraindication of oxaliplatin or capecitabine. 4. History of the serious hypersensitivity for any agents. 5. History of pelvic irradiation. 6. Uncontrolled active infection. 7. Clinically significant complication (heart failure, interstitial lung disease or pulmonary fibrosis, uncontrolled diabetes, renal failure, liver failure, etc.) 8. Evidence of peripheral sensory neuropathy. 9. Uncontrolled diarrhea. 10. Uncontrolled pleural effusion or ascites. 11. Multiple primary cancer within 5 years. 12. Possible pregnant, pregnant or breast-feeding female. 13. Other conditions not suitable for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method R0 resection rate
- Secondary Outcome Measures
Name Time Method Safety (incidence of adverse events), Pathological complete response (pCR), Down-staging rate, Disease-free survival (DFS), local recurrence rate