advanced lower rectal cancer lower rectal cancer
Conditions
Interventions
Clinical study with approved drugs and radiation
Sponsors
Shimada Mitsuo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients satisfied fully with below criteria 1) Diagnosed as adenocarcinoma 2) cT2~T4 and cN0~N3, resectable case 3) Tumor location (including Rb region) 4) Measurable tumor 5) No peritoneal dissemination 6) No distant metastasis 7) 20~80 years old 8) Performance status 0~2 9) Patinets with normal organ function 10) No pre treatment 11) Patientss with informed consent 12) Patients able to take foods orally
Exclusion criteria
Exclusion criteria: 1) Interstitial pneumonia 2) Much ascites or pleural effusion 3) Double cancer or treated cancer less than 5 years disease free survival 4) Strong stenosis(fiber cannot pass through) 5) Peritoneal dissemination 6) Infection,Ileus 7) Severe diarrhea 8) Severe diabete mellitus 9) Severe hyper tension 10)Heart failure,liver failure,renal failure 11) Past history of thrombosis 12) Intraabdominal inflammation 13) Severe paresthesia or perceived failure 14) Brain metastasis 15) Congenital hemorrhagic disorder or blood coagulation disorder 16) Psychiatric disorder 17) Pregnant woman or patients hoping of pregnancy 18) Past history of severe drug allergy 19) Contraindication of each trial drugs 20) Past history of drug allergy for each trial drugs 21) Continuous steroids administration 22) Patients with anti-coagulant drugs 23) Patients ncompatible with this trial judged by medical staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate(RR),relapse free survival(RFS) over all survival(OS),safety(adverse events rate complication rate),local recurrence rate complete therapy rate R0 resection rate,down staging rate | — |
Contacts
Public ContactTakuya Tokunaga
Tokushima University
Outcome results
None listed