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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033658
Receipt No. R000038371
Official scientific title of the study Drug Use-Results Survey of Erbitux (Injection 100 mg) for EGFR-Positive, Curatively Unresectable Advanced or Recurrent Colorectal Cancer Patients
Date of disclosure of the study information 2018/08/08
Last modified on 2018/08/07

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Basic information
Official scientific title of the study Drug Use-Results Survey of Erbitux (Injection 100 mg) for EGFR-Positive, Curatively Unresectable Advanced or Recurrent Colorectal Cancer Patients
Title of the study (Brief title) Drug Use-Results Survey of Erbitux (mCRC)
Region
Japan

Condition
Condition EGFR-Positive, Curatively Unresectable Advanced or Recurrent Colorectal Cancer
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose is to detect unlisted adverse drug reactions (ADRs) of Erbitux (especially clinically significant ADR), to obtain the ADR profile of the product in clinical practice, and to identify any factor that affects the safety and effectiveness.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes (Safety)
1-1. Profile of ADRs/infections reported (types, grades, and incidence rates, etc.)
1-2. Factors potentially affecting the safety of Erbitux (analyzing the types and incidence rates of ADRs/infections by patient demographic and baseline characteristics)
Key secondary outcomes (Effectiveness)
1. Factors potentially affecting the effectiveness of Erbitux (analyzing the effective rate by patient demographic and baseline characteristics)

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All patients who were administrated Erbitux for patient with EGFR-Positive, Curatively Unresectable Advanced or Recurrent Colorectal Cancer (mCRC).
Key exclusion criteria Patients who do not give a full consent to this survey.
Target sample size 1800

Research contact person
Name of lead principal investigator Satoshi Kameyama
Organization Merck Serono Co., Ltd.
Division name PMS Planning & Strategy, Medical Department
Address Arco Tower 4F, 1-8-1, Shimomeguro, Meguro-ku, Tokyo, Japan
TEL 03-6756-0743
Email satoshi.kameyama@merckgroup.com

Public contact
Name of contact person Hiroshi Suzuka
Organization Merck Serono Co., Ltd.
Division name PMS Planning & Strategy, Medical Department
Address Arco Tower 4F, 1-8-1, Shimomeguro, Meguro-ku, Tokyo, Japan
TEL 03-6756-0837
Homepage URL
Email hiroshi.suzuka@merckgroup.com

Sponsor
Institute Merck Serono Co., Ltd.
Institute
Department

Funding Source
Organization Merck Serono Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

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 08 Month 08 Day

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 08 Month 25 Day
Anticipated trial start date
2009 Year 10 Month 05 Day
Last follow-up date
2010 Year 12 Month 22 Day
Date of closure to data entry
2016 Year 07 Month 26 Day
Date trial data considered complete
2016 Year 07 Month 26 Day
Date analysis concluded
2016 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results Published
URL releasing results
Results
Other related information All-case survey

Management information
Registered date
2018 Year 08 Month 07 Day
Last modified on
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038371

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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