UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031177
Receipt No. 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

* 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 Precision medicine for patients with RAS wild metastatic colorectal cancer by using liquid biopsy
Acronym RAS-liquid
Scientific Title Precision medicine for patients with RAS wild metastatic colorectal cancer by using liquid biopsy
Scientific Title:Acronym RAS-liquid
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

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

Assessment
Primary outcomes Response rate
Key secondary outcomes The rate of Early tumor shrinkage
Progression free survival
Overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Liquid biopsy to detect RAS mutation
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Yamada
Organization Nippon medical school
Division name Digestive Surgery
Zip code
Address 1-1-5 Sendagi, Bunkyo-Ku, Tokyo, Japan
TEL 03-3822-2131
Email y-tak@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Yamada
Organization Nippon Medical School
Division name Digestive Surgery
Zip code
Address 1-1-5 Sendagi, Bunkyo-Ku, Tokyo, Japan
TEL 03-3822-2131
Homepage URL
Email y-tak@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 07 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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 06 Day
Last modified on
2018 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035597

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.