Phase I/II study of preoperative treatment with XELOXIRI(CPT-11, L-OHP, capecitabine) with Cetuximab in patients with RAS wild type-advanced colorectal cancer
- Conditions
- locally advanced rectal cancer
- Registration Number
- JPRN-UMIN000032784
- Lead Sponsor
- Sapporo Medical University School of Medicine Department of Surgery, Surgical Oncology and Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
Not provided
1) Any major surgical treatments within 4 weeks. 2) Prior chemotherapy or radiotherapy. 3) Pulmonary fibrosis or interstitial pneumonia. 4) Watery stool or diarrhea. 5) Active infection and inflammation or HBs antigen positive. 6) uncontrollable heart failure, renal failure, peptic ulcer, intestinal paralysis, ileus and diabetes mellitus. 7) synchronous or metachronous (within 3 years) malignancy other than carcinoma in situ 8) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. Men with no intention to practice birth control. 9) Severe mental disease. 10) History of the severe hypersensitivity. 11) Patients homozygous for UGT1A1*28, or UGT1A1*6, or heterozygous for both UGT1A1*28 and UGT1A1*6. 12) CTCAE v4.0>Grade1 of peripheral neuropathy. 13) Inadequate physical condition, as diagnosed by primary physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method