Unique ID issued by UMIN | UMIN000030030 |
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Receipt number | R000034286 |
Scientific Title | TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial |
Date of disclosure of the study information | 2018/03/01 |
Last modified on | 2019/05/21 10:10:27 |
TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial
TAS-CC4 Study
TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial
TAS-CC4 Study
Japan |
metastatic colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
YES
The efficacy and safety of TAS-102 plus Bevacizumab combination (5-day treatment followed by a 9-day rest period) as third line therapy for colorectal cancer
Safety,Efficacy
Phase II
progression free survival
Response rate , overall survival,
Safety, and incidence of Grade 3 neutropenia
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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
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
45
1st name | Takeshi |
Middle name | |
Last name | Yamada |
Nippon Medical School
Digestive Surgery
113-8602
1-1-5 Sendagi, Bunkyo-Ku, Tokyo, Japan
03-3822-2131
y-tak@nms.ac.jp
1st name | Takeshi |
Middle name | |
Last name | Yamada |
Nippon Medical School
Digestive Surgery
113-8602
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
03-3822-2131
y-tak@nms.ac.jp
Department of Digestive Surgery,Nippon Medical School
Department of Digestive Surgery, Nippon Medical School
Self funding
Japan
q
q
03-3822-2131
clinicaltrial@nms.ac.jp
NO
2018 | Year | 03 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2018 | Year | 11 | Month | 16 | Day |
2018 | Year | 12 | Month | 01 | Day |
2017 | Year | 11 | Month | 18 | Day |
2019 | Year | 05 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034286
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