UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027108
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public 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.
Acronym The optimal cut off value of KRAS testing
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.
Scientific Title:Acronym The optimal cut off value of KRAS testing
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 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.
Basic objectives2 Others
Basic objectives -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.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression-free survival (PFS)
Key secondary outcomes Overall response rate (ORR)
Disease Control Rate (DCR)
Overall survival (OS)
Safety

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 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





Key exclusion criteria 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
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Suzuki
Organization Jichi Medical University, Saitama Medical Center
Division name Department of Surgery
Zip code 330-8503
Address 1-847 Amanuma, Saitamacity, Saitama, 330-8503, Japan
TEL 048-647-2111
Email ksuzbnhm@omiya.jichi.ac.jp

Public contact
Name of contact person
1st name Suzuki
Middle name
Last name Koichi
Organization Jichi Medical University, Saitama Medical Center
Division name Department of Surgery
Zip code 330-8503
Address 1-847 Amanuma, Saitamacity, Saitama, 330-8503, Japan
TEL 048-647-2111
Homepage URL
Email ksuzbnhm@omiya.jichi.ac.jp

Sponsor
Institute Department of Surgery, Jichi Medical University, Saitama Medical Center,
1-847 Amanuma, Saitamacity, Saitama, 330-8503, Japan.
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Jichi Medical University, Saitama Medical Center
Address 1-847 Amanuma, Omiya, Saitama 330-8503, Japan.
Tel 048-647-2111
Email ksuzbnhm@omiya.jichi.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2017 Year 04 Month 28 Day
Date of IRB
2017 Year 04 Month 24 Day
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2018 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 04 Month 24 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031053

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.