Phase2 study of perioperative XELOX in patients with locally-advanced lower rectal cancer
Phase 2
- Conditions
- Rectal cancer
- Registration Number
- JPRN-UMIN000008203
- Lead Sponsor
- Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
Not provided
Exclusion Criteria
1) Need to drain malignant coelomic fluid. 2) With distant metastases 3) Multiple primary cancer within 5years 4) Symptomatic or asymptomatic but treated heart disease 5) History of the serious hypersensitivity for Fluorouracil, platinum compound and levofolinate calcium 6) History of adverse events related to DPD loss 7) Uncontrolled Diarrhea 8) Peripheral neuropathy(Grade1<=) 9) Uncontrolled infection 10) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 11) No intention to practice birth control 12) Previously treated with oxaliplatin 13) Other conditions not suitable for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2 year disease free survival
- Secondary Outcome Measures
Name Time Method Operation rate, Safety, Down staging rate, Pathological complete response rate, Pathological effect, 2 year local recarence rate