Rectal cancer
Conditions
Interventions
Neo-Adjuvant chemotherapy XELOX+ bevacizumab 3cycle followed by XELOX 1cycle Resection 3-8weeks after last chemotherapy dose
Sponsors
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Written informed consent. (2) Age: 20-74 years old. (3) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. (4) Histological confirmation of rectal cancer. (5) Clinical stage T4 and/or lymph node positive. (6) Low rectal cancer. (7) No prior radio or chemo therapy (8) Vital organ functions listed below are preserved within 2 weeks prior to entry. 1. WBC 4,000 /mm3 and over 2. Nertrophil 2000 /mm3 and over 3. Platelet 100,000 /mm3 and over 4. Hemoglobin 9.0 g/dl and over 5. Total bilirubin 1.5 ml/dl and less 6. AST and ALT 100 IU/l and less 7. Creatinine 1.5 mg/dl and less
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety(Adverse event, Complication) | — |
Secondary
| Measure | Time frame |
|---|---|
| Resectability Down staging rate Pathological complete response rate Pathological effect | — |
Countries
Japan
Contacts
Public ContactMasataka Ikeda Tsunekazu Mizushima
Osaka University Graduate School of Medicine Department of Surgery
Outcome results
None listed