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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001934
Receipt No. 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

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Basic information
Public title Evaluating amphiregulin in plasma for metastatic colorectal cancer treated with cetuximab based therapy
Acronym Amphiregulin expresssed in mCRC treated with cetuximab
Scientific Title Evaluating amphiregulin in plasma for metastatic colorectal cancer treated with cetuximab based therapy
Scientific Title:Acronym Amphiregulin expresssed in mCRC treated with cetuximab
Region
Japan

Condition
Condition unresectable metastatic colorectal cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of irinotecan plus cetuximab between higher and lower 100pg/ml amphiregulin in plasma expressing group of mCRC refractory to irinotecan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes disease control rate between higher and lower amphiregulin group
Key secondary outcomes response rate
Time to progression
Overall survival

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

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimio Yonesaka MD PhD
Organization Kinki University School of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-2 Ohno-Higashi, Osaka-Sayama-shi, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kinki University School of Medicine
Division name Department of Medical Oncology
Zip code
Address
TEL 0723-66-0221
Homepage URL
Email

Sponsor
Institute Kinki University School of Medicine, Department of medical oncology
Institute
Department

Funding Source
Organization Kinki University School of Medicine, Department of medical oncology
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 05 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2009 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2016 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This trial is prospective study.

Management information
Registered date
2009 Year 05 Month 02 Day
Last modified on
2016 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002355

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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