UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001934
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

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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 or person

Institute

Kinki University School of Medicine, Department of medical oncology

Institute

Department

Personal name



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

Value
https://center6.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