Unique ID issued by UMIN | UMIN000027108 |
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Receipt number | R000031053 |
Scientific Title | The optimal cut off value of KRAS testing for the selection of unresectable colorectal cancer patients more likely to benefit from treatment with anti-EGFR in the first line setting. |
Date of disclosure of the study information | 2017/06/01 |
Last modified on | 2019/04/30 08:51:55 |
The optimal cut off value of KRAS testing for the selection of unresectable colorectal cancer patients more likely to benefit from treatment with anti-EGFR in the first line setting.
The optimal cut off value of KRAS testing
The optimal cut off value of KRAS testing for the selection of unresectable colorectal cancer patients more likely to benefit from treatment with anti-EGFR in the first line setting.
The optimal cut off value of KRAS testing
Japan |
Colorectal cancer
Gastrointestinal surgery |
Malignancy
YES
To determine the optimal cut off value of KRAS testing for the selection of unresectable colorectal cancer patients more likely to benefit from treatment with mFOLFOX6 + Cmab / Pmab therapy in the first line setting.
Others
Progression-free survival is compared in consideration of the percentage of KRAS mutant clones, such as 1-5,5-10,10-25%, determined by Digital PCR.
Progression-free survival (PFS)
Overall response rate (ORR)
Disease Control Rate (DCR)
Overall survival (OS)
Safety
Observational
20 | years-old | <= |
85 | years-old | > |
Male and Female
1,Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer.
2,Age greater than or equal to 20 years at the time of informed consent
3,KRAS wild type (exon2 codon12,13)determined by direct sequencing. RAS mutations in exon 3,4 are excluded.
4,ECOG performance status (PS) of 0-2
5,Written informed consent prior to study-specific screening procedure
6,Life expectancy of at least 90 days
7,Withdrawal from first-line chemotherapy (regardless of containing molecular-targeted drugs) for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last dose of adjuvant chemotherapy
8,Adequate organ function according to following laboratory values obtained within 14 days before enrollment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test)
i. Neutrophil count: > or = 1500/mm3
ii.Platelet count: > or = 10.0 x 104/mm3
iii.Hemoglobin: > or = 9.0 g/dL
iv.Total bilirubin: < or = 1.5 mg/dL
v.AST, ALT: < or =1.5100 IU/L
(< or = 200 IU/I if liver metastases present)
vi.Serum creatinine: < or =1.5 mg/dL
1) History of other malignancy with a disease-free interval <5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)
2) With massive pleural effusion or ascites requiring intervention
3) Radiological evidence of brain tumor or brain metastases
4) Active infection including hepatitis
5) Any of the following concurrent diseases:
i. Gastrointestinal bleeding or gastrointestinal obstruction (including paralytic ileus)
ii. Symptomatic heart disease (including unstable angina, myocardial infarction, and heart failure)
iii. Interstitial pneumonia or pulmonary fibrosis
iv. Uncontrolled diabetes mellitus
v. Uncontrolled diarrhea (that interferes with daily activities despite adequate therapy)
6) Any of the following medical history:
i. Myocardial infarction: History of one episode within one year before enrollment or two or more lifetime episodes
ii. Serious hypersensitivity to any of the study drugs
iii. History of adverse reaction to fluoropyrimidines suggesting dihydropyrimidine dehydrogenase (DPD) deficiency
7) Previous treatment with irinotecan hydrochloride
8) Current treatment with atazanavir sulfate
9) Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment
10) Pregnant or lactating females, and males and females unwilling to use contraception
100
1st name | Koichi |
Middle name | |
Last name | Suzuki |
Jichi Medical University, Saitama Medical Center
Department of Surgery
330-8503
1-847 Amanuma, Saitamacity, Saitama, 330-8503, Japan
048-647-2111
ksuzbnhm@omiya.jichi.ac.jp
1st name | Suzuki |
Middle name | |
Last name | Koichi |
Jichi Medical University, Saitama Medical Center
Department of Surgery
330-8503
1-847 Amanuma, Saitamacity, Saitama, 330-8503, Japan
048-647-2111
ksuzbnhm@omiya.jichi.ac.jp
Department of Surgery, Jichi Medical University, Saitama Medical Center,
1-847 Amanuma, Saitamacity, Saitama, 330-8503, Japan.
Takeda Pharmaceutical Co., Ltd.
Profit organization
Jichi Medical University, Saitama Medical Center
1-847 Amanuma, Omiya, Saitama 330-8503, Japan.
048-647-2111
ksuzbnhm@omiya.jichi.ac.jp
NO
2017 | Year | 06 | Month | 01 | Day |
Unpublished
Terminated
2017 | Year | 04 | Month | 28 | Day |
2017 | Year | 04 | Month | 24 | Day |
2017 | Year | 06 | Month | 01 | Day |
2018 | Year | 11 | Month | 30 | Day |
none
2017 | Year | 04 | Month | 24 | Day |
2019 | Year | 04 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031053
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