UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004694 |
|---|---|
| Receipt number | R000005587 |
| Scientific Title | Conversion therapy of Cetuximab plus FOLFIRI followed by Bevacizumab plus mFOLFOX6 in patients with liver metastatic colorectal cancer |
| Date of disclosure of the study information | 2010/12/10 |
| Last modified on | 2018/09/27 11:24:44 |
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Basic information
Public title
Conversion therapy of Cetuximab plus FOLFIRI followed by Bevacizumab plus mFOLFOX6 in patients with liver metastatic colorectal cancer
Acronym
N-SOG 04
Scientific Title
Conversion therapy of Cetuximab plus FOLFIRI followed by Bevacizumab plus mFOLFOX6 in patients with liver metastatic colorectal cancer
Scientific Title:Acronym
N-SOG 04
Region
| Japan |
Condition
Condition
Unresectable colorectal liver metastases
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Cetuximab plus FOLFIRI followed by Bevacizumab plus mFOLFOX6 as a conversion therapy for the patients with unresectable or recurrent liver metastatic colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Liver resection rate after chemotherapy with Bevacizumab plus mFOLFOX6(R0/R1)
Key secondary outcomes
Liver resection rate(Overall)
Liver resection rate after chemotherapy with Cetuximab plus FOLFIRI(R0/R1)
Response rate
Disease control rate
Safety
Morbidity
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 with Cetuximab plus FOLFIRI followed by Bevacizumab plus mFOLFOX6.
Treatment repeats every 14 days for up to 12 courses (6 courses for Cetuximab plus FOLFIRI and 6 courses for Bevacizumab plus mFOLFOX6) .
Liver resection (if possible)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Histopathologically confirmed colorectal cancer
(2)KRAS wild type(Codon13 and/or 12)
(3)Unresectable liver metastases without extrahepatic metastasis or reccurrence
(4)No prior chemotherapy with Oxaliplatin,Irinotecan,Bevacizumab and Cetuximab
(5)Age: 20 years to 75 years
(6)ECOG performance status: 0-1
(7)No severe organ failure and suitable results of all laboratory test
a. WBC: >=3,000/mm3
b. Neutrophil count: >=1,500/mm3
c. Platelet count: >=100,000/mm3
d. Hemoglobin: >=8.0g/dL
e. Total billilubin: <=2 times the institutional upper limit of normal
f. AST and ALT: <=5 times the institutional upper limit of normal
g. Serum creatinine: <=2 times the institutional upper limit of normal
h. ECG normal or minor abnormality with no-need of treatment
(8)A life expectancy of more than 6 month
(9)Written informed consent will be obtained from each patient before enrollment
Key exclusion criteria
(1)Severe myelosuppression
(2)Diarrhea(watery)
(3)Require treatment of serious infection
(4)Uncontrolled body cavity fluid
(5)Comorbidity or history of interstitial lung disease or pulmonary fibrosis
(6)Severe hypersensitivity
(7)Renal failure or urine protein >=+2 within 1 week before enrollment
(8)Uncontrollable hypertension or diabetes
(9)Significant abnormal ECG or history of cardiovascular disease within 1year
(10)Thrombosis with present or history of thromboembolism within 1year
(11)Intestinal bleeding, ileus, bowel obstruction or peptic ulcer
(12)Perforation of gastrointestinal tract within 1year
(13)Administrated with Aspirin (>=325mg/day) or steroid for rheumatoid arthritis and chronic inflammatory disease
(14)Pregnant and lacting woman,woman with suspected pregnancy, and men of the fertility hope
(15)Have anti-thrombosis drugs within 7days before enrollment
(16)Need to treatment with Atazanavir sulfate
(17)Active multiple cancers
(18)Severe mental illness
(19)Treated continuously with systemic steroids
(20)Any subject judged by the investigator to be unfit for any reason to participate in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nagino |
Organization
Nagoya University Graduated School of Medicine
Division name
Division of Surgical Oncology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL
052-744-2222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Uehara |
Organization
Nagoya University Graduated School of Medicine
Division name
Division of Surgical Oncology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL
052-744-2222
Homepage URL
kuehara@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Surgical Oncology Group
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
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
名古屋大学医学部附属病院（愛知県）他、関連病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | 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 | 12 | Month | 09 | Day |
Last modified on
| 2018 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005587
