Pilot study of preoperative chemotherapy of XELOX+ Bevacizumab in patients with locally-advanced lower rectal cancer

Not Applicable

• Conditions: Rectal cancer

• Registration Number: JPRN-UMIN000003219
• Lead Sponsor: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

(1)With malignant coelomic fluid. (2)With distant metastases (3)Multiple primary cancer within 5 years (4)With arterial thromboembolism, e.g. cerebrovascular disease (5)Any surgical treatments including skin-open biopsy, surgery of trauma and other more intensive surgery within 4 weeks or aspiration biopsy within one week. (6)Administering antithrombotic drug within 10 days. (7)Need to administrate or having anti-platelets therapy (including aspirin and NSAIDS) (8)Bleeding tendency or coagulation disorder (INR 1.5 and over) (9)Symptom of colorectal obstruction (10)Uncontrolled complication of peptic ulcer (11)Current or previous (within the last 1 year) history of GI perforation (12)Serious renal complications or having 2+ uric protein (13)Uncontrolled hypertension (14)Symptomatic or asymptomatic but treated heart disease (15)History of the serious hypersensitivity for Fluorouracil, platinum compound and levofolinate calcium (16)History of adverse events related to DPD loss (17)Uncontrolled Diarrhea (18)Peripheral neuropathy (Grade1<=) (19)Uncontrolled infection (20)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (21)No intention to practice birth control (22)Previously treated with bevacizumab or oxaliplatin (23)Other conditions not suitable for this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety(Adverse event, Complication)

Secondary Outcome Measures

Name	Time	Method
Resectability Down staging rate Pathological complete response rate Pathological effect