TAS-CC4 Study

JRCT ID: jRCTs031180424

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 25/12/2017
• Target sample size: 45
• Study type: Interventional

Intervention(s)

TAS-102: 35mg/m2 given orally twice daily on days 1-5 and 15-19 in a 28-day cycle.
Bevacizumab: 5mg/kg given intravenously in a 2-week cycle

Outcome(s)

• Primary Outcome: progression free survival
• Secondary Outcome: Response rate , overall survival, Safety, and incidence of Grade 3 neutropenia

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

1)Histologically proven colorectal cancer
2)patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s)
3)treatment history of two or more regimens for metastatic colorectal cancer, and who has confirmed PD in imaging study
4)20<= and 80>= years old
5)ECOG performance status of 0 or 1
6)With measurable lesions according
7)ability to tolerate oral drug administration
8)a life expectancy of at least 3 months
9)Patient who has adequate main organ functions in tests within 14 days beforeenrollment
-leukocyte >=3,500/mm3
-neutrophil >=1,500/mm3
-platelet >=75,000/mm3
-haemoglobin concentorarion >=8.0 g/dL
-serum total bilirubin level <=1.5 mg/dLserum creatinine <=1.5 mg/dL
-serum AST and ALT levels <2.5x Upper limit of normal (ULN).
-serum creatinine <=1.5 mg/dL
-Peripheral neuropathy<=grade2
-Diarrhea and NonHaematotoxicity =<grade1
10)gave written informed consent

Exclude 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)other active malignancies
7)have pleural effusion and ascitic fluid with the treatment
8)Comorbidity or history of heart failure
9)gastrointestinal ulcer or bleeding
10)previous hemoptysis
11)Clinical or radiological evidence of CNS metastases
12)Current or previous (within the last 6 months) history of GI perforation
13)Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study
14)ongoing treatment with anticoagulant
15)Synchronous or metachronous multiple malignancy within the last 5 year disease free interval
16)Under continuous steroid administration
17)decision of unsuitable for this study by the investigator

Related Information

• Primary Sponsor: Yamada Takeshi
• Secondary ID(s): UMIN000030030