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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004694
Receipt No. 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

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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
Email

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
Email kuehara@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya Surgical Oncology Group
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
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005587

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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