UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Conversion therapy of Cetuximab plus FOLFIRI followed by Bevacizumab plus mFOLFOX6 in patients with liver metastatic colorectal cancer
Title of the study (Brief title)	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	Masato Nagino
Organization	Nagoya University Graduated School of Medicine
Division name	Division of Surgical Oncology
Address	65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL	052-744-2222
Email

Public contact
Name of contact person	Keisuke Uehara
Organization	Nagoya University Graduated School of Medicine
Division name	Division of Surgical Oncology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 08 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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