Unique ID issued by UMIN | UMIN000022437 |
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Receipt number | R000025859 |
Scientific Title | TAS-102 and Bevacizumab as second line chemotherapy for colorectal cancer. Phase 2 trial |
Date of disclosure of the study information | 2016/08/01 |
Last modified on | 2016/05/24 20:25:39 |
TAS-102 and Bevacizumab as second line chemotherapy for colorectal cancer. Phase 2 trial
TAS-102 and Bevacizumab as second line chemotherapy for colorectal cancer. Phase 2 trial (TAS-CC2 study)
TAS-102 and Bevacizumab as second line chemotherapy for colorectal cancer. Phase 2 trial
TAS-102 and Bevacizumab as second line chemotherapy for colorectal cancer. Phase 2 trial (TAS-CC2 study)
Japan |
metastatic colorectal cancer
Gastrointestinal surgery |
Malignancy
NO
The efficacy and safety of TAS-102 plus Bevacizumab combination as second line therapy for colorectal cancer
Safety,Efficacy
Phase II
progression free survival
Time to Treatment Failure, response rate , overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
TAS-102: 35mg/m2 given orally twice a day in a 28-day cycle, 2-week cycle of 5 days treatment followed by a 2-day rest period, and then a 14-day rest period
Bevacizumab: 5mg/kg given intravenously in a 2-week cycle
Not applicable |
Not applicable |
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 one 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) standard second therapy not eligibility
9) a life expectancy of at least 3 months
10) Patient who has adequate main organ functions in tests within 14 days before enrollment 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/dL serum 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
11) 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) Peritoneal metastases at image
12) Clinical or radiological evidence of CNS metastases
13) Current or previous (within the last 6 months) history of GI perforation
14) Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study
15) ongoing treatment with anticoagulant
16) Synchronous or metachronous multiple malignancy within the last 5 year disease free interval
17) Under continuous steroid administration
18) decision of unsuitable for this study by the investigator
20
1st name | |
Middle name | |
Last name | Keiji Koda |
Teikyo University Chiba Medical Center
Surgery
3426-3 Anesaki, Ichihara City, Chiba 2990111, Japan
0436621211
k-koda@med.teikyo-u.ac.jp
1st name | |
Middle name | |
Last name | Takeshi Yamada |
Nippon medical school hospital
Digestive Surgery
1-1-5 Sendagi, Bunkyo-Ku, Tokyo
03-3822-2131
y-tak@nms.ac.jp
Teikyo University Chiba Medical Center
Self funding
Self funding
Japan
NO
帝京大学ちば総合医療センター
日本医科大学付属病院
2016 | Year | 08 | Month | 01 | Day |
Unpublished
Preinitiation
2016 | Year | 05 | Month | 18 | Day |
2016 | Year | 06 | Month | 01 | Day |
2016 | Year | 05 | Month | 24 | Day |
2016 | Year | 05 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025859
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