UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004197 |
|---|---|
| Receipt number | 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 13:12:21 |
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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
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
wataru@ndmc.ac.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005044
