UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of biweekly cetuximab therapy for unresectable colorectal cancer
Title of the study (Brief title)	Phase II study of biweekly cetuximab therapy
Region	Japan

Condition
Condition	unresectable colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the safety and efficacy of biweekly administration of cetuximab.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Adverse event Disease control rate Disease free 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	Medicine
Interventions/Control_1	biweekly administration of cetuximab
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)Eligible patients had to have a histologically verified adenocarcinoma of the colon and rectum. 2)Adequate bone marrow, liver, renal, and cardiac function 3)The patient with KRAS-wild type tumor
Key exclusion criteria	1)other co-existing malignancy 2)severe concurrent medical orpsychiatric illness 3)patients were pregnant or lactating.
Target sample size	10

Research contact person
Name of lead principal investigator	Kiyoshi Maeda
Organization	Osaka City University
Division name	Department of Surgical Oncology
Address	1-4-3Asahimachi, Abeno-ku, Osaka, Japan
TEL	06-6645-3838
Email	m1378386@med.osaka-cu.ac.jp

Public contact
Name of contact person	Kiyoshi Maeda
Organization	Osaka City University Hospital
Division name	Department of Surgical Oncology
Address	1-4-3Asahimachi, Abeno-ku, Osaka, Japan
TEL	06-6645-3838
Homepage URL
Email	m1378386@med.osaka-cu.ac.jp

Sponsor
Institute	Department of Surgical Oncology Osaka City University
Institute
Department

Funding Source
Organization	Osaka City University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2013 Year 08 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 19 Day
Anticipated trial start date	2013 Year 06 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 08 Month 03 Day
Last modified on	2016 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007057