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TAS-102 and Bevacizumab as salvage line chemotherapy for colorectal cancer

Phase 2
Conditions
Colorectal Cancer
Registration Number
JPRN-UMIN000031790
Lead Sponsor
Surgical Oncology Association in Chiba (SOAC)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
45
Inclusion Criteria

Not provided

Exclusion Criteria

1)contraindications for TAS-102 and BEvacizumab 2)previously received chemotherapy with TAS-102 3)severe drug allergy 4)pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy. 5)patient who has important clinical complications(symptomatic unstable ischemic heart disease, arrhythmia, acute myocardial infarction within 6 months, liver cirrhosis, renal failure, active gastrointestinal ulcer, ileus, uncontrolled diabetes, uncontrolled hypertension, etc.) 6)have pleural effusion and ascitic fluid with the treatment 7)previous hemoptysis (over 25ml of fresh blood) 8)current or previous (within the last 6 months) history of GI perforation 9)patient with thrombosis (within the last 6 months) 10)patient with bleeding tendency 11)synchronous or metachronous multiple malignancy within the last 5 year disease free interval 12)dicision of unsuitable for this study by the investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Progression Free Survival
Secondary Outcome Measures
NameTimeMethod
1)Overall Survival 2)Time to Treatment Failure 3)Response Rate 4)Disease control rate 5)Adverse events 6)Relation between RAS status and effectiveness of chemotherapy 7)Relation between location of tumor and effectiveness of chemotherapy 8)Relation between the timing when chemotherapy started and effectiveness of chemotherapy
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