advanced rectal cancer
Conditions
Interventions
S-1 80mg/m2, irinotecan 40mg/m2, oxaliplatin dose level 1-3
Sponsors
Department of Gastrointestinal and Pediatric 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 or N1-3 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 of lactating and woman with childbearing potential who lacked effective contaception 3)Man who lacked effective contraception 4)With uncontrolled renal failure 5)With uncontrolled heart disease 6)With severe plumonary disease 7)With gastrointestinal bleeding, obstruction, perforation 8)With active inflammatory bowel disease 9)With active infection 10)With large amount of ascites, pleural effusion, or pericardial effusion 11)Any other cases who are regarded as inadequate for study enrollment by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD,DLT,RD | — |
Countries
Japan
Contacts
Public ContactYasuhiro Inoue
Mie University Graduate School of Medicine Department of Gastrointestinal and Pediatric Surgery
Outcome results
None listed