Unique ID issued by UMIN | UMIN000021664 |
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Receipt number | R000024979 |
Scientific Title | TAS-102 plus Bevacizumab combination as salvage therapy in elderly patients with metastatic colorectal cancer, phase 2 trial |
Date of disclosure of the study information | 2016/04/26 |
Last modified on | 2016/03/29 11:14:09 |
TAS-102 plus Bevacizumab combination as salvage therapy in elderly patients with metastatic colorectal cancer, phase 2 trial
TAS-102 plus Bevacizumab as salvage therapy in elderly patients with metastatic colorectal cancer
TAS-102 plus Bevacizumab combination as salvage therapy in elderly patients with metastatic colorectal cancer, phase 2 trial
TAS-102 plus Bevacizumab as salvage therapy in elderly patients with metastatic colorectal cancer
Japan |
metastatic colorectal cancer
Gastroenterology |
Malignancy
NO
The efficacy and safety of TAS-102 plus Bevacizumab combination as salvage therapy in elderly metastatic colorectal cancer patients
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
overall survival
progression free survival, response rate , disease control rate, relative dose intensity, frequency and grade of adverse events
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
70 | years-old | <= |
Not applicable |
Male and Female
1) patient who has histologically or cytologically confirmed colorectal adenocarcinoma
2) patient who has confirmed K-RAS status of colorectal cancer
3) patient who has a treatment history of one or more regimens for metastatic colorectal cancer, and who is refractory or intolerant to them
4) patient who has at least one measurable lesion in imaging study within 28 days before enrollment(not essential criteria)
5) patient who is 70 years or older, and considered to be intorelant to other strong chemotherapeutic regimens after one or more strong regimens
6) patient with an ECOG Performance Status of between 0 and 2
7) patient with ability to tolerate oral drug administration
8) patient who has adequate main organ functions in tests within 14 days before enrollment
neutrophil count >=1,500/mm3
platelet count >=100,000/mm3
haemoglobin concentorarion >=9.0 g/dL
serum total bilirubin level <=1.5 mg/dL
serum AST and ALT levels <=100 U/L
serum creatinine <=1.5 mg/dL
9) patient who has a life expectancy of at least 3 months
10) written informed consent got from the patient
1) patient who had previously received chemotherapy with TAS-102
2) patient who has history of hemoptysis(>=25mL, fresh blood)
3) patient with other active malignancies
4) patient with symptomatic brain metastasis
5) patients with serious pleural effusion, ascites or pericardial effusion
6) patients with active infection
7) Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study
8) 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.)
9) patient with non-healing wound or traumatic bone fracture
10) patient with bleeding disorders or current use of anticoagulant
11) patient with severe drug allergy
12) male patient who hoping partner's pregnancy
13) patient who has at least either one of HIV antibody, HBs antigen, or HCV antibody
14) patient who given a dicision of unsuitable for this study by the investigator
25
1st name | |
Middle name | |
Last name | Tetsuji Takayama |
Tokushima University Hospital
Gastroenterology and Oncology
2-50-1 Kuramoto Tokushima-City Tokushima, Japan
088-633-7124
takayama@tokushima-u.ac.jp
1st name | |
Middle name | |
Last name | Tetsuji Takayama |
Institute of Biomedical Sciences, Tokushima University Graduate School
Gastroenterology and Oncology
3-18-15 Kuramoto Tokushima-city, Tokushima Japan
088-633-7124
takayama@tokushima-u.ac.jp
Tokushima University Hospital
None
Self funding
None
None
NO
徳島大学病院(徳島県)
国立病院機構北海道がんセンター(北海道)
斗南病院(北海道)
小樽掖済会病院(北海道)
製鉄記念室蘭病院(北海道)
徳島赤十字病院(徳島県)
2016 | Year | 04 | Month | 26 | Day |
Unpublished
Preinitiation
2016 | Year | 04 | Month | 26 | Day |
2016 | Year | 04 | Month | 26 | Day |
2016 | Year | 03 | Month | 29 | Day |
2016 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024979
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