UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009630 |
|---|---|
| Receipt number | 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 21:15:03 |
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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
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
miyahide@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba graduate school of medicine Department of frontier surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011300
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| Registered date | File name |
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