UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006402 |
|---|---|
| Receipt number | R000007535 |
| Scientific Title | Multicenter Phase II Study of FOLFOX Plus Bi-weekly Cetuximab as First Line Treatment in Patients with Metastatic Colorectal Cancer |
| Date of disclosure of the study information | 2011/09/26 |
| Last modified on | 2013/03/29 13:45:41 |
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Basic information
Public title
Multicenter Phase II Study of FOLFOX Plus
Bi-weekly Cetuximab as First Line Treatment in Patients with Metastatic Colorectal Cancer
Acronym
CELINE Trial
Scientific Title
Multicenter Phase II Study of FOLFOX Plus
Bi-weekly Cetuximab as First Line Treatment in Patients with Metastatic Colorectal Cancer
Scientific Title:Acronym
CELINE Trial
Region
| Japan |
Condition
Condition
Metastatic Colorectal Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation about FOLFOX plus bi-weekly cetuximab as first Line treatment in patients with metastatic colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
1) Early tumor shrinkage (at week 8)
2) Response rate in target organ
3) Desease control rate
4) Progression free survival
5) Overall survival
6) Efficacy and safety of 5-FU/LV/Cetuximab
7) Safety
8) Ro resection rate
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
Chemotherapy regimen
mFOLFOX6 +Cetuximab
Cetuximab 500mg/m2/biweekly
Oxaliplatin 85mg/m2/biweekly
l-LV 200mg/m2/biweekly
5-FU/bolus 40mg/m2/biweekly
5-FU/infusional
2400mg/m2/biweekly
( day1-3:46h)
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 metastatic colorectal cancer (mCRC)
2) Inoperable mCRC
3) KRAS mutations (codons 12/13) were not detected
4) Presence of at least one measurable lesion using the RECIST (ver1.1 guidelines)
5) No prior chemotherapy for mCRC
6) Relapse over 24 weeks of adjuvant chemotherapy with Oxialiplatin
7) Age over 20 years
8) ECOG PS 0,1
9) Adequate organ functions
10)Written informed consent
Key exclusion criteria
No serious myelosuppression
2)No sensory alteration or paresthesia interfering with function
3)No mental disease or neurovascular disease
4)No radiotherapy to target lesion
5)No severe stenosis by primary lesion
6)No hypersensitivity for test drugs
7)No serious infection
8)No cardiovascular disease, complication
9)No brain metastasis,
10)No large quantity of abdominal or pleural effusion
11)No diarrhea,
12)No active double cancer
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Kondo |
Organization
Nagoya Medical Center
Division name
Surgery
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya University
Division name
Course in Healthcare administration
Zip code
Address
65 Tsurumai, Shouwa-ku, Nagoya
TEL
Homepage URL
Sponsor or person
Institute
Epidemiological and Clinical Research Information Network
Institute
Department
Personal name
Funding Source
Organization
Epidemiological and Clinical Research Information Network
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 09 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
| 2011 | Year | 09 | Month | 24 | Day |
Last modified on
| 2013 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007535
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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