UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of cetuximab plus 5-FU/LV for unresectable colorectal cancer
Acronym	Phase II study of cetuximab plus 5-FU/LV for unresectable colorectal cancer
Scientific Title	Phase II study of cetuximab plus 5-FU/LV for unresectable colorectal cancer
Scientific Title:Acronym	Phase II study of cetuximab plus 5-FU/LV for unresectable colorectal cancer
Region	Japan

Condition
Condition	Unresectable colorectal cancer
Classification by specialty	Medicine in general Gastroenterology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Anti tumor effect and safety
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	response rate
Key secondary outcomes	disease control rate, progression free survival, overall survival, toxicity, QOL

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	cetuximab plus 5-FU/LV
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	Histological proven unresectable colorectal cancer KRAS wild Measurable lesions according to RECIST criteria Following previous treatment - refractory to 5-FU - failure or refractory or intolerant of irinotecan - refractory or failure to oxaliplatin Adequate interval from previous treatments Adequate organ function Age of 20 years or older ECOG performance status 0-2 Expected more than 8 weeks survival Written informed consent from patient
Key exclusion criteria	Symptomatic brain metastasis Sever wattery diarrhea Paralytic or mechanical bowel obstruction Confirmed or suspected infection Severe pulmonary disease Severe comorbidity Pregnant or possibly pregnant, and nursing women Sever neurologic disease Receiving atazanavir sulfate Past history of monoclonal antibody sever allergy Past history of 5-FU/LV sever allergy Past history of treatment with Anti-EGFR Other conditions not suitable for this study
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Muro
Organization	Aichi Cancer Center Hospital
Division name	Department of Clinical Oncology
Zip code	464-8681
Address	1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
TEL	0527626111
Email	h.taniguchi@aichi-cc.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Ura
Organization	Aichi Cancer Center Hospital
Division name	Department of Clinical Oncology
Zip code	464-8681
Address	1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
TEL	052-762-6111
Homepage URL
Email	tura@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization	None
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	ACCH IRB
Address	1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
Tel	052-762-6111
Email	yterasima@aichi-cc.jp

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	2012 Year 12 Month 05 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	Completed
Date of protocol fixation	2012 Year 10 Month 30 Day
Date of IRB	2012 Year 10 Month 15 Day
Anticipated trial start date	2012 Year 12 Month 06 Day
Last follow-up date	2015 Year 12 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 12 Month 05 Day
Last modified on	2021 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011144