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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004197
Receipt No. R000005044
Scientific Title Phase II Study of FOLFOX + Erbitux as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type
Date of disclosure of the study information 2010/09/13
Last modified on 2016/11/24

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Basic information
Public title Phase II Study of FOLFOX + Erbitux as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type

Acronym JACCRO CC-05 study

Scientific Title Phase II Study of FOLFOX + Erbitux as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type

Scientific Title:Acronym JACCRO CC-05 study

Region
Japan

Condition
Condition Metastatic colorectal cancer

Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of cetuximab + FOLFOX as first line in metastatic colorectal cancer with EGFR-detectable and KRAS wild type

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response Rate

Key secondary outcomes Overall Survival
Progression Free Survival
Safety
Best response; % change at baseline

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 mFOLFOX6+cetuximab
Cetuximab loading dose 400mg/sqm,250 mgsqm/week
L-OHP 85 mg/sqm/biweekly
Levofolinate 200 mg/sqm/biweekly
5-FU bolus 400 mg/sqm/biweekly
5-FU continuous 2,400 mg/sqm/biweekly
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients with histologically proven colorectal cancer
2.Metastatic colorectal cancer with EGFR expressed
3.KRAS wild type in codon 12, 13
4.Presence of measurable lesion (RECIST Ver.1.1)
5.no prior chemotherapy for unresectable primary tumor, metastases and lymph node metastasis. No primar therapy including surgery for recurrent that should be the first relapse after surgery for primary or metastases tumors
6.ECOG Performance Status(PS) 0-1
7.Age between 20 to 79 years
8.Life expectancy of more than 3 months
9.Patiens have enough organ function for study treatment
10.Written informed consent

Key exclusion criteria 1.Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval
2.Symptomatic brain metastases
3.Severe infectious disease
4.Interstitial lung disease or pulmonary fibrosis
5.Comorbidity or history of heart failure
6.Sensory alteration or paresthesia interfering with function
7.Large quantity of pleural, abdominal or cardiac effusion
8.Severe comorbidity (renal failure, liver failure, hypertension, etc)
9.Prior radiotherapy for primary and metastases tumors
10.Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
11.History of severe allergy
12.History of allergy for L-OHP and other platinating agent
13.Prior treatment of cetuximab or L-OHP
14.Any other cases who are regarded as inadequate for study enrollment by investigators
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wataru Ichikawa
Organization National Defense Medical College Hospital

Division name Department of Clinical Oncology
Zip code
Address 3-2 Namiki, Tokorozawa, Saitama, Japan, 359-8513
TEL 04-2995-1211
Email wataru@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Wataru Ichikawa
Organization National Defense Medical College Hospital
Division name Department of Clinical Oncology
Zip code
Address 3-2 Namiki, Tokorozawa, Saitama, Japan, 359-8513
TEL 04-2995-1211
Homepage URL
Email wataru@ndmc.ac.jp

Sponsor
Institute Japan Clinical Cancer Research Organization

Institute
Department

Funding Source
Organization Japan Clinical Cancer Research Organization

Organization
Division
Category of Funding Organization Non profit foundation
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
2010 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://link.springer.com/article/10.1007/s11523-016-0445-6
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
2010 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 13 Day
Last modified on
2016 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005044

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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