UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of preoperative chemotherapy with mFOLFOX6+Bevacizumab in patients with liver-only metastases (H2, H3) from colorectal cancer; histological assessment of liver damage from preoperative chemotherapy.
Title of the study (Brief title)	Safety and efficacy of preoperative chemotherapy with mFOLFOX6+Bevacizumab in patients with liver-only metastases (H2, H3) from colorectal cancer; histological assessment of liver damage from preoperative chemotherapy.(KSCC0802)
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 mFOLFOX6+Bevacizumab in patients with liver-only metastases (H2, H3) from colorectal cancer; histological assessment of liver damage from preoperative chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Liver resection rate
Key secondary outcomes

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+Bevacizumab was administered for six cycles, but sixth cycle of therapy did not include Bevacizumab. Surgery was planned 2 weeks after the last dose of chemotherapy, resulting in a gap of 6-9 weeks between surgery and the last Bevacizumab dose.
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. colorectal cancer, cytologically and/or histrogically 2. with measurable lesions in the live only (no extrahepatic disease) 3. degree of liver metastases: H2, H3 4. no prior chemotherapy 5. no prior radiotherapy 6. age: 20-75 years old 7. Performance status(ECOG):0, 1 8. Life expectancy estimated >= 3 months 9. Sufficient organ functions 10. written informed consents
Key exclusion criteria	1. Administering antithrobotic drug within 7 days 2. Serious drug hypersensitivity or a history of drug allergy 3. Peripheral neuropathy 4. Active concomitant malignancy 5. Active infections 6. Serious complications (renal failure or hepatic failure) 7. High blood pressure and diabetic and hypercalcemia that cannot be controlled 8. symptomatic or asymptomatic but treated heart disease 9. interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema 10. histry of mental disturbances or cerebrovascular attack 11. Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer 12. Current or previous (within one year) history of GI perforation 13. Plerral effusion, peritoneal fluid and pericardial fluid 14. Symptomatic brain metastasis 15. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 16. under coutinuous steroid therapy 17. Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week 18. CV-port procedure within one week 19. Anti-platelets therapy (including aspirin and NSAIDS) 20. Bleeding tendency, coagulation abnormality 21. history of organ transplantation 22. Traumatic gracture of unrecovery 23. Bevacizumab used previous chemotherapy 24. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 25. Other conditions not suitable for this study
Target sample size	39

Research contact person
Name of lead principal investigator	Maehara Yoshihiko
Organization	Kyushu University
Division name	Dpt. of surgery and science
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582
TEL	092-631-2920
Email	info2@cres-kyushu.or.jp

Public contact
Name of contact person	Clinical Research Support Center Kyushu
Organization	CReS kyushu
Division name	KSCC
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan, 812-8582
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	CReS kyushu
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

九州大学（福岡県） 国立病院機構九州医療センター（福岡県） 公立学校共済組合九州中央病院（福岡県） 済生会福岡総合病院（福岡県） 福岡歯科大学医科歯科総合病院（福岡県） 済生会八幡総合病院（福岡県） 新日鐵八幡記念病院（福岡県） 社会保険田川病院（福岡県） 社会保険仲原病院（福岡県） 久留米大学（福岡県） 久留米大学医療センター（福岡県） 聖マリア病院（福岡県） 麻生飯塚病院（福岡県） 福岡市民病院（福岡県） 国立病院機構嬉野医療センター（佐賀県） 済生会唐津病院（佐賀県） 有田共立病院（佐賀県） 佐世保市立総合病院（長崎県） 長崎大学（長崎県） 光晴会病院（長崎県） 国立病院機構長崎医療センター（長崎県） 済生会熊本病院（熊本県） 熊本赤十字病院（熊本県） 熊本大学（熊本県） 熊本地域医療センター（熊本県） 健康保険人吉総合病院（熊本県） 健康保険八代総合病院（熊本県） 熊本市立熊本市民病院（熊本県） 天草地域医療センター（熊本県） 荒尾市民病院（熊本県） 大分大学（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） 中津市立中津市民病院（大分県） 大分県済生会日田病院（大分県） 小林市立病院（宮崎県） 宮崎県立延岡病院（宮崎県） 社会保険宮崎江南病院（宮崎県） 国立病院機構都城病院（宮崎県） 国立病院機構南九州病院（鹿児島県） 今給黎総合病院（鹿児島県） 潤愛会　鮫島病院（鹿児島県） 鹿児島大学（鹿児島県） 鹿児島厚生連病院（鹿児島県） 慈愛会　今村病院（鹿児島県） 済生会川内病院（鹿児島県） 県民健康プラザ鹿屋医療センター（鹿児島県） 鹿児島県立薩南病院（鹿児島県） 浦添総合病院（沖縄県） 中頭病院（沖縄県） 琉球大学（沖縄県） 広島赤十字・原爆病院（広島県） 松山赤十字病院（愛媛県） 防府消化器病センター　防府胃腸病院（山口県）

Other administrative information
Date of disclosure of the study information	2008 Year 08 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 06 Month 17 Day
Anticipated trial start date	2008 Year 06 Month 17 Day
Last follow-up date	2010 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/?term=KSCC0802
Results
Other related information

Management information
Registered date	2008 Year 08 Month 08 Day
Last modified on	2017 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001586