UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of neoadjuvant chemotherapy with Bevacizumab plus FOLFOX6 chemotherapy for Resectable case of liver metastasis
Acronym	Before study
Scientific Title	Phase II trial of neoadjuvant chemotherapy with Bevacizumab plus FOLFOX6 chemotherapy for Resectable case of liver metastasis
Scientific Title:Acronym	Before study
Region	Japan

Condition
Condition	synchronous metastatic liver tumors of 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	Evaluate the feasibility and efficacy of neoadjuvant chemotherapy with Bevacizumab plus FOLFOX6 chemotherapy for resectable case of synchronous liver metastasis from colo-rectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	response rate
Key secondary outcomes	safety, R-resection rate pathological response change of Grading disease free survival progression free survival overall survival

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	Neoadjuvant chemotherapy with mFOLFOX6x1, mFOLFOX6+Bevacitumab x 6 and mFOLFOX6x1 followd by resection of origin
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 diagnosed by histopathology 2. first treatment for measurable synchronous liver metastases. Curative cases by D2 or D3 resection. 3. Enrollment is within 6 weeks after original resection. 4. Written informed consent. 5. Age are from 20 to 74 years old. 6. PS by ECOG is 0 and 1. 7. a life expectancy greater than 3 months. 8. Function of main organ is kept as below, adequate hematologic function (leucocyte count > 3,000/uL, granulocyte count > 1,500/uL, hemoglobin level > 9.0 g/dL, and platelet count > 100,000/uL), adequate renal function (serum creatinine concentration < 1.5). Total bilirubin is within 1.5 times of normal limits. AST and ALT are within 5 times of normal limits. ALP is within 5 times of normal limits. Creatinin is within normal limits. (7) Written informed consent 9. Criteria of operable metastases are below, 1. Within 10 metastases, 2. Liver function is A by Child-Pough classification. 3. Operable case is judged by HBP surgeon.
Key exclusion criteria	1. No extrahepatic lesion 2. No carcinomatous fluid 3. No brain tumor and brain metastases 4. Another cancer with disease free survival within 5 year 5. No cranial nerve and vessel problem, and no past history within 1 year of cranial nerve and vessel problem 6. Operation and incisional biopsy within 2 weeks. Or punctual cytology within 1 week. 7. Thrombosis with present and past history 8. Oral taking with Aspirin and steroid for RA and chronic inflammatory disease 9. Bleeding tendency and clotting abnormality 10. Uncontrollable peptic ulcer disease 11. Perforation of GI tract within 1 year 12. Untreatment of traumatic bone fracture 13. Require treatment of renal dysfunction, or urine protein > +2 within 2 weeks. 14. Uncontrollable hypertension 15. Cardiac disease (over Grade 2 by CTCAE v3.0). Or myocardial infarction within 1 year. 16. No severe anaphylaxis of Leucovorin(LV), 5-Fluorouracil(5-FU) and L-OHP 17. Uncontrollable diarrhea 18. interstitial lung disease, pulmonary fibrosis 19. organ recipient receiving an immunosuppressant 20. Uncontrollable infection 21. pregnant woman, lactating woman, positive of pregnancy test. Or no willing of birth-control 22. case whom principal investigator deny the enrollment.
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Middle name Last name Michiaki Unno
Organization	Tohoku University Graduate School of Medicine
Division name	Tohoku University Graduate School of Medicine, Division of Hepato-Biliary Pancreatic Surgery
Zip code
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL	022-717-7205
Email	m_unno@surg1.med.tohoku.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kei Nakagawa
Organization	Miyagi HBPCOG
Division name	Division of Hepato-Biliary Pancreatic Surgery
Zip code
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL	022-717-7205
Homepage URL
Email	kein_h11@surg1.med.tohoku.ac.jp

Sponsor
Institute	Miyagi HBPCOG
Institute
Department

Funding Source
Organization	Tohoku University Graduate School of Medicine, Division of Hepato-Biliary Pancreatic Surgery
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

Other administrative information
Date of disclosure of the study information	2008 Year 12 Month 12 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	No longer recruiting
Date of protocol fixation	2008 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date	2008 Year 06 Month 01 Day
Last follow-up date	2013 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2008 Year 12 Month 12 Day
Last modified on	2015 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001888

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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