Phase I/II study of preoperative treatment with capecitabine, oxaliplatin and irinotecan (XELOXIRI) in patients with advanced colorectal cancer

Phase 1

• Conditions: locally advanced rectal cancer

• Registration Number: JPRN-UMIN000009974
• Lead Sponsor: Osaka University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

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