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

JRCT ID: jRCTs061180081

Registered date:20/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: advanced lower rectal cancer
• Date of first enrollment: 12/05/2014
• Target sample size: 47
• Study type: Interventional
• Intervention(s): Clinical study with approved drugs and radiation

Outcome(s)

• Primary Outcome: pCR rate

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Shimada Mitsuo
• Secondary ID(s): 13267