NIPH Clinical Trials Search

JRCT ID: jRCTs061180081

Registered date:20/03/2019

Preoperative chemoradiothrepy for lower advanced rectal cancer patients using SOX+Bev regimen.

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedadvanced lower rectal cancer
Date of first enrollment12/05/2014
Target sample size47
Countries of recruitment
Study typeInterventional
Intervention(s)Clinical study with approved drugs and radiation


Primary OutcomepCR rate
Secondary OutcomeResponse 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

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
Include criteriaPatients 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
Exclude criteria1) 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

Related Information


Public contact
Name Takuya Tokunaga
Address 3-18-15 Kuramoto-cho,Tokushima Tokushima Japan 770-8503
Telephone +81-886337139
Affiliation Tokushima University
Scientific contact
Name Mitsuo Shimada
Address 3-18-15 Kuramoto-cho,Tokushima Tokushima Japan 770-8503
Telephone +81-886337139
Affiliation Tokushima University