Unique ID issued by UMIN | UMIN000031177 |
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Receipt number | R000035597 |
Scientific Title | Precision medicine for patients with RAS wild metastatic colorectal cancer by using liquid biopsy |
Date of disclosure of the study information | 2018/07/01 |
Last modified on | 2018/02/06 22:40:06 |
Precision medicine for patients with RAS wild metastatic colorectal cancer by using liquid biopsy
RAS-liquid
Precision medicine for patients with RAS wild metastatic colorectal cancer by using liquid biopsy
RAS-liquid
Japan |
metastatic colorectal cancer
Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
Malignancy
YES
This study evaluated the clinical utility of KRAS mutations in cfDNA to predict primary or secondary resistance of EGFR blockade as first-line treatment of metastatic colorectal cancer.
Efficacy
Response rate
The rate of Early tumor shrinkage
Progression free survival
Overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
Liquid biopsy to detect RAS mutation
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1)Histologically proven colorectal cancer
2)RAS wild type
3)patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s)
4)No treatment history for metastatic colorectal cancer
5)20<= and 80>= years old
6)ECOG performance status of 0 or 1
7)With measurable lesions according
8)well dietary intake
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 EGFR blockades
2)previously received chemotherapy with EGFR blockades
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)Clinical or radiological evidence of CNS metastases
10)Synchronous or metachronous multiple malignancy within the last 5 year disease free interval
11)Under continuous steroid administration
12)decision of unsuitable for this study by the investigator
100
1st name | |
Middle name | |
Last name | Takeshi Yamada |
Nippon medical school
Digestive Surgery
1-1-5 Sendagi, Bunkyo-Ku, Tokyo, Japan
03-3822-2131
y-tak@nms.ac.jp
1st name | |
Middle name | |
Last name | Takeshi Yamada |
Nippon Medical School
Digestive Surgery
1-1-5 Sendagi, Bunkyo-Ku, Tokyo, Japan
03-3822-2131
y-tak@nms.ac.jp
Nippon Medical School
None
Other
NO
2018 | Year | 07 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 10 | Month | 19 | Day |
2017 | Year | 11 | Month | 01 | Day |
2018 | Year | 02 | Month | 06 | Day |
2018 | Year | 02 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035597
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