UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer(KSCC1002)
Acronym	Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer(KSCC1002)
Scientific Title	Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer(KSCC1002)
Scientific Title:Acronym	Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer(KSCC1002)
Region	Japan

Condition
Condition	Patients with liver-only metastases from colorectal cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Liver resection rate
Key secondary outcomes	Liver resection rate in patients with H2 metastases Liver resection rate in patients with H3 metastases Progression Free Survival Overall Survival Response rate Safety R0 resection rate Response rate in liver metastases Pathological response 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	L-OHP 130mg/m2 i.v. (day1) Cmab 250mg/m2 i.v. (only the first time Cmab 400mg/m2) S-1 80mg/m2 (day1-14) to be repeated every 3 weeks for 4 cycles. Surgery was planned after SOX+Cetuximab therapy.
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.Written informed consent 2.Appropriate for the study at the physician's assessment 3.Histopathology confirmed colorectal cancer. 4.KRAS wild-type. 5.With measurable lesions in the liver only. 6.degree of liver metastases: H2, H3 7.No prior therapy 8.ECOG performance status of 0-1. 9.Aged 20<= years. 10.considered to survive for more than 3 months. 11Required baseline laboratory parameters (within 14 days before registration): WBC >= 3000 ,<12000/mm3 Neu >= 1,500/ mm3 Plt >= 100,000/ mm3 Hb >= 9.0g/dl T-Bil <= 2.0mg/dl AST,ALT<= 200U/L Cre <1.5mg/dl Ccr >= 50mL/min 12.be able to take oral drugs
Key exclusion criteria	1.Prior liver or pulmonary resection. 2.Administering antithrombotic drug within 7 days. 3.History of serious drug hypersensitivity or a history of drug allergy 4.Peripheral neuropathy 5.Active other malignancies. 6.Active infection. 7.Serious complications (renal failure or hepatic failure) 8.High blood pressure and diabetic and hypercalcemia that cannot be controlled 9.symptomatic or asymptomatic but treated heart disease 10.interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema 11.histry of mental disturbances, central nervous system disorder or cerebrovascular attack 12.Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer 13.Pleural effusion peritoneal fluid and pericardial fluid 14.Symptomatic brain metastasis 15.Watery stools or diarrhea 16.under continuous steroid therapy 17.Requiring flucytosine, phenytoin, Warfarin Potassium. 18.Infection with hepatitis B or C virus 19.Pregnant or lactating woman 20.No birth-control 21.Not appropriate for the study at the physician's assessment
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideo Baba
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Dept. of Gastroenterological Surgery
Zip code
Address	1-1-1 Honjo, Kumamoto, 860-8556, Japan.
TEL	092-631-2920
Email	kscc2@cres-kyushu.or.jp

Public contact
Name of contact person	1st name Middle name Last name KSCC
Organization	Clinical Research Support Center Kyushu
Division name	KSCC
Zip code
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
TEL	092-631-2920
Homepage URL
Email	kscc2@cres-kyushu.or.jp

Sponsor
Institute	Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
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
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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

九州大学病院（福岡県）、国立病院機構九州がんセンター（福岡県）、製鉄記念八幡病院（福岡県）、社会保険田川病院（福岡県）、福岡市民病院（福岡県）、福岡大学病院（福岡県）、長崎大学病院(腫瘍外科)（長崎県）、熊本大学病院（熊本県）、済生会熊本病院（熊本県）、熊本中央病院（熊本県）、健康保険人吉総合病院（熊本県）、荒尾市民病院（熊本県）、熊本地域医療センター（熊本県）、大分大学病院（大分県）、大分赤十字病院（大分県）、国立病院機構大分医療センター（大分県）、国立病院機構別府医療センター（大分県）、国立病院機構都城病院（宮崎県）、鹿児島共済会南風病院（鹿児島県）、慈愛会今村病院（鹿児島県）、中頭病院（沖縄県）、佐世保市立総合病院（長崎県）、広島赤十字・原爆病院（広島県）、国立病院機構福岡東医療センター（福岡県）、熊本市立熊本市民病院（熊本県）、済生会福岡総合病院（福岡県）、松山赤十字病院（愛媛県）、国立病院機構南九州病院（鹿児島県）、福岡大学筑紫病院（福岡県）、公立八女総合病院（福岡県）、今給黎総合病院（鹿児島県）、久留米大学医療センター（福岡県）、天草地域医療センター（福岡県）、久留米大学病院（福岡県）、国立病院機構九州医療センター（福岡県）、済生会八幡総合病院（福岡県）、鹿児島大学（鹿児島県）、大分県立病院（大分県）、高野会高野病院（熊本県）、宗像医師会病院（福岡県）、中津市立中津市民病院（大分県）、公立学校共済組合九州中央病院（福岡県）、社会保険仲原病院（福岡県）、宮崎県立延岡病院（宮崎県）、鹿児島県立薩南病院（鹿児島県）、高知医療センター（高知県）、神戸市立医療センター中央市民病院（兵庫県）、国立病院機構再春荘病院（熊本県）、長崎大学病院（移植・腫瘍外科）（長崎県）、九州大学病院別府病院（大分県）

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 06 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	Completed
Date of protocol fixation	2010 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date	2010 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	2010 Year 10 Month 06 Day
Last modified on	2017 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005188

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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