Unique ID issued by UMIN | UMIN000001934 |
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Receipt number | R000002355 |
Scientific Title | Evaluating amphiregulin in plasma for metastatic colorectal cancer treated with cetuximab based therapy |
Date of disclosure of the study information | 2009/05/02 |
Last modified on | 2016/05/02 13:06:19 |
Evaluating amphiregulin in plasma for metastatic colorectal cancer treated with cetuximab based therapy
Amphiregulin expresssed in mCRC treated with cetuximab
Evaluating amphiregulin in plasma for metastatic colorectal cancer treated with cetuximab based therapy
Amphiregulin expresssed in mCRC treated with cetuximab
Japan |
unresectable metastatic colorectal cancer
Hematology and clinical oncology |
Malignancy
NO
To compare the efficacy of irinotecan plus cetuximab between higher and lower 100pg/ml amphiregulin in plasma expressing group of mCRC refractory to irinotecan.
Efficacy
disease control rate between higher and lower amphiregulin group
response rate
Time to progression
Overall survival
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1,Age>20y.o.
2,histologically confirmed unresectable mCRC
3,Prior treated with irinotecan, for at least 6weeks or more.
4,Radiographically disease progressed during or within 3 month following irinotecan.
5,Failure from fluoropyrimidine- and oxaliplatin-based chemotherapies.
6,ECOG PS 0-2
7,immunohistochemical evidense of EGFR expression
8,At least 2weeks non therapy since previous therapy
9,Prescence of measurable lession by CT scan or MRI.
10,no prior therapy with EGFR inhibitor
11,adequate organ function
White blood cell count>3,000/m3
Hb>9.0g/dl
Plt>100,000/m3
T-Bil<1.5mg/dl
AST, ALT<200IU/l
Serum creatinine<1.5mg/dl
12,Life expectancy of at least 3 months
13,Written informed consent
1,symptomatic brain metastasis
2,serious pleural effusion or ascites
3,active infection
4,uncontrolled heart disease, diabetes and hypertension
5,diarrhea, watery stool
6,uncontrolled colonic or small bowel disorder
7,intestinal pneumonia of lung fibrosis
8,pregnancy or lactation period
100
1st name | |
Middle name | |
Last name | Kimio Yonesaka MD PhD |
Kinki University School of Medicine
Department of Medical Oncology
377-2 Ohno-Higashi, Osaka-Sayama-shi, Osaka, Japan
1st name | |
Middle name | |
Last name |
Kinki University School of Medicine
Department of Medical Oncology
0723-66-0221
Kinki University School of Medicine, Department of medical oncology
Kinki University School of Medicine, Department of medical oncology
Self funding
NO
2009 | Year | 05 | Month | 02 | Day |
Published
Completed
2009 | Year | 03 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
This trial is prospective study.
2009 | Year | 05 | Month | 02 | Day |
2016 | Year | 05 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002355
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