Locally advanced rectal cancer
Conditions
Interventions
bevacizumab 5kg/m2, 5FU dose level 1-3
Sponsors
Department of Gastrointestinal and Paediatric Surgery Division of Reparative Medicine Institute of Life Sciences Mie University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically confirmed rectal adenocarcinoma 2)T3 or T4 disease 3) ECOG PS 0-1 4)Expectation of over 3 months survival 5)Patients with adequate main organ function 6)Patient with written informed consent
Exclusion criteria
Exclusion criteria: 1)Previous history of drug-induced allergy 2)Pregnant or lactating and woman with childbearing potential who lacked effective contraception 3)Man who lacked effective contraception 4)Evidence of thronbosis and need anti-coagulability drugs 5)With uncontrolled renal failure 6)With uncontrolled hypertention 7)With uncontrolled heart disease 8)With severe plumonary disease(intestinal pneumotitis, pulmonary fibrosis) 9)With gastrointestinal bleeding,obstruction, perforation 10) With active inflammatory bowel disease 11)With active infection 12)With brain metastasis 13)Synchronous or metachronous malignancy 14) Patient who received surgery within 28 days at registration 15) Any other cases who are regard as inadequate for study enrollment by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD RD | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of non-dose limitting toxicities, Resection rate | — |
Countries
Japan
Outcome results
None listed