Rectal cancer
Conditions
Interventions
SOX+bevacizumab: 3 courses Bevacizumab 7.5mg/kg day1 L-OHP 130mg/m2 day1 S-1 80-120mg/day day1 (after dinner)-15(after breakfast) every 3 weeks SOX: 1 course L-OHP 130mg/m2 day1 S-1 80-120mg/day
Sponsors
Asahikawa Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed adenocarcinoma of the rectum 2) Patients meet all the following criteria by radiological or physical examination before enrollment i) Main part of the tumor is located in Ra, Rb, P (Rs should be excluded) ii) Distal border of the tumor is located between peritoneal reflection and anal verge 3) Patients meet either of the following criteria by CT, MRI, or endorectal ultrasound i) Tumors invade mesorectum beyond rectal muscularis propria *Tumors which directly invade other organs should be excluded ii) Lymph node metastases are in the mesorectum (>10 mm in short axis) * Lymphadenopathy (>5 mm in short axis) in the lateral position should be excluded 4) ECOG Performance Status of 0-1 5) Age of 20 to 80 years 6) Adequate major organ functions within 2 weeks before enrollment, as defined below: WBC count => 3,000/mm3, <= 12,000/mm3 Neutrophil count => 1,500/mm3 Platelet count => 100,000/mm3 Hemoglobin => 9.0 g/dL Total bilirubin <= 1.5 x ULN AST <= 2.5 x ULN ALT <= 2.5 x ULN ALP <= 5.0 x ULN Creatinine <= 1.5 x ULN CCr => 60 ml/min urinary protein <= 1+ INR <= 1.5 7) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Any distant metastases 2) Neurological disorder by cerebrovascular disorder within a year before enrollment 3) Symptomatic heart disease or heart disease requiring treatment. Cardiac infarction within a year before enrollment 4) Pleural, peritoneal and pericardial effusion 5) Prior systematic chemotherapy, pelvic irradiation and/or surgery for malignant tumor 6) Active double cancer. Asynchronous double cancer with disease-free duration of 5 years or less. (Including colorectal cancer) 7) Interstitial pneumonia or pulmonary fibrosis 8) Poorly controlled infection 9) Grade 2 or worse peripheral neuropathy 10) Bowel obstruction (Patients with diverting stoma are allowed for enrollment) 11) Poorly controlled diarrhea 12) Confirmed or possible pregnancy, lactation, willingness to become pregnant (for women), or willingness to have a child (for men) 13) Contraindication of bevacizumab 14) Physician concludes that the patient's participation in this trial is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | — |
Countries
Japan
Contacts
Public ContactMasahiro Yamada
Asahikawa Medical University Division of Gastroenterologic and General Surgery
Outcome results
None listed