Phase2 trial of Preoperative chemotherapy with XELOX prus Bv for resectable liver metastases from colorectal cancer

Phase 2

Recruiting

• Conditions: colon cancer

• Registration Number: JPRN-UMIN000007931
• Lead Sponsor: Sano HospitalGastrointestinal Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1.clinical or radiological evidence of CNS metastases. 2. current or previous (within the last 1 year) history of cerebrovascular disease 3.major surgical procedure, open biopsy or significant traumatic injury except for CV-port procedure within 28 days prior to Day 0 4.serious non-healing fracture 5.current or previous (within the last 1 year) history of GI perforation 6.serious non-healing ulcer 7.evidence of bleeding diathesis or coagulopathy. 8.current or recent (within 10 days prior to enrllment) ongoing treatment with anticoagulants for therapeutic purposes 9.ongoing treatment with aspirin (> 325 mg/day) 10.clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction 11.uncontrolled hypertension 12. serious renal failure, 1+ or higher proteinuria within 2 weeks prior to enrollment 13.uncontrolled pleural and/or peritoneal effusion 14.past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated: - Basal and squamous cell carcinoma of the skin - In-situ carcinoma of the cervix 15.interstitial lung disease, or pulmonary fibrosis 16.uncontrolled infection 17.history of organ 18. diarrhea >= Grade 2 according to the Common Toxicity Criteria of the National Cancer Institute, version 3. 19.pregnancy (positive serum pregnancy test) and lactation 20.serious drug hypersensitivity or a history of drug allergy 21.history of adverse events related to fluorouracil 22.with liver cirrhosis and/or Viral hepatitis 23.Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified