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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009630
Receipt No. R000011300
Scientific Title Feasibility study of Pre-operative FOLFIRI3 plus cetuximab for KRAS wild type resectable advanced colorectal cancer (mCRC).
Date of disclosure of the study information 2013/01/01
Last modified on 2019/12/31

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Basic information
Public title Feasibility study of Pre-operative FOLFIRI3 plus cetuximab for KRAS wild type resectable advanced colorectal cancer (mCRC).
Acronym Pre-operative FOLFIRI3 plus cetuximab study.
Scientific Title Feasibility study of Pre-operative FOLFIRI3 plus cetuximab for KRAS wild type resectable advanced colorectal cancer (mCRC).
Scientific Title:Acronym Pre-operative FOLFIRI3 plus cetuximab study.
Region
Japan

Condition
Condition Resectable advanced colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and the safety of surgery and pre-operative chemotherapy(FOLFIRI3 plus Cetuximab) for resectable advanced colorectal cancer as feasibility study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Treatment completion rate
Key secondary outcomes Tumor reduction rate(4cycles & 8cycle),Response rate,
Histological therapeutic effect,safety,Postoperative complication

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 Maneuver
Interventions/Control_1 Pre-operative chemotherapy(FOLFIRI3 plusCetuximab)4cycles
=>To evaluate effect
=>Surgical resection or Continued chemotherapy
=>Surgical resection.
*FOLFIRI3 plus Cetuximab
Cetuximab500 mg/m2/day1/q2w
CPT-11 100 mg/m2/day1,3/q2w
I-LV 200 mg/m2/day1/q2w
5-FU/infusional 2400 mg/m2/46hr/q2w
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) Histologically confirmed colorectal cancer.
2) KRAS wild type in codon 12, 13.
3) A measurable lesion or an evaluable lesion is confirmed with an objectivity document according to RECIST standard.
4) Resectable metastatic colorectal cancer
5) No prior chemotherapy.
6) Age over 20 years.
7) ECOG Performance Status 0-2.
8) Adequate organ function for study treatment.
9) A life expectancy of more than 3 months.
10) Written informed consent.
Key exclusion criteria 1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval.
2) Patients who have brain metastases.
3) Severe myelosuppression.
4) Severe infections.
5) Patients who have interstitial pneumonitis or past histories of interstitial pneumonitis and/or pulmonary fibrosis.
6) Severe heart failure or past histories of heart failure.
7) Sever dysfunctional paresthesia or dysesthesia.
8) Patient who have massive cancer-malignant effusion (e.g, pleural effusion, ascites, pericardial effusion)
9) Severe complications (e.g.,renal failure, hepatic failure or high blood pressure ).
10) Patient who have intestinal paralysis or bowel obstruction .
11) Patient who have jaundice.
12) Patients who have given a dose of atazanavir sulfate.
13) Pregnant woman, nursing mothers, possibly pregnant woman and wishing to become pregnant.
14) History of severe allergy.
15) Patient who have given Cetuximab or CPT-11before enrollment.
16) The Patient that a study responsibility physician judged to be inappropriate.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Hisahiro
Middle name
Last name Matsubara
Organization Chiba graduate school of medicine
Division name Department of frontier surgery
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-226-2110
Email matsuhm@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Hideaki
Middle name
Last name Miyauchi
Organization Chiba graduate school of medicine
Division name Department of frontier surgery
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-226-2110
Homepage URL
Email miyahide@faculty.chiba-u.jp

Sponsor
Institute Chiba graduate school of medicine Department of frontier surgery
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 Chiba University Hospital Clinical research center
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
Tel 043-222-7171
Email undisclosed

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 01 Month 01 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 06 Month 18 Day
Date of IRB
2012 Year 06 Month 18 Day
Anticipated trial start date
2013 Year 01 Month 09 Day
Last follow-up date
2016 Year 06 Month 30 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 25 Day
Last modified on
2019 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011300

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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