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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001961
Receipt No. R000002303
Scientific Title Pre-operative chemotherapy with mFOLFOX6+Bevacizumab in liver only metastases from colorectal cancer -Phase II feasibility study-
Date of disclosure of the study information 2009/06/01
Last modified on 2009/05/12

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Basic information
Public title Pre-operative chemotherapy with mFOLFOX6+Bevacizumab in liver only metastases from colorectal cancer
-Phase II feasibility study-
Acronym FITS 0801
Scientific Title Pre-operative chemotherapy with mFOLFOX6+Bevacizumab in liver only metastases from colorectal cancer
-Phase II feasibility study-
Scientific Title:Acronym FITS 0801
Region
Japan

Condition
Condition colorectal cancers
Classification by specialty
Gastroenterology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of liver resection for metastatic lesions from colorectal cancers after neoadjuvant chemotherapy (mFOLFOX6+bevacizumab)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Feasibility
Key secondary outcomes R0(have tumor free margin) + R1(no tumor free margin)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
Maneuver
Interventions/Control_1 Surgery
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 1,2) Histologically or cytologically confirmed colorectal cancer confined to the liver
3) No extrahepatic metastases (If present, primary tumor must be potentially resectable with curative intent)
4) Measurable disease
5) Resectable or unresectable disease
6) No prior chemotherapy or radiotherapy (Prior adjuvant chemotherapy for primary cancer is allowed provided it is other than FOLFOX and at least 24 weeks have passed since last treatment)
7) No prior locoregional therapy for liver metastases
8) Age 20 to 75 years old
9) ECOG performance status 0-1
10) Life expectancy of &>13 weeks at the time of enrollment
11) Adequate organ functions as follows:
WBC 4,000-12,000/mm3
ANC>2,000/mm3
Platelet count>100,000 /mm3
Hemoglobin>9 g/dL
AST or ALT< 3 times ULN
Bilirubin<1.5 times ULN
Creatinine<1.5 times ULN
12) Written informed consent.
Key exclusion criteria 1) Active or previous history of interstitial pneumonia or pulmonary fibrosis confirmed by chest X-ray
2) Fluid retention requiring treatment
3) Other active malignancies unless the patient has been disease-free and received no treatment for the malignancy for &<5 years prior to study entry.
4) Peripheral neuropathy
5) Active infectious diseases
6) Ileus, Diarrhea
7) Diabetes mellitus, uncontrolled or controlled with chronic insulin therapy
8) Gastrointestinal perforation either concurrently or within 1 year prior to study entry
9) Previous history of ischemic heart disease
10,13) Psychiatric or medical condition that would preclude study compliance
11) Positive for HIV antibody and/or HBs antigen and/or HCV antibody
12) Concurrent chronic steroid therapy
14) Concurrent antithrombotic therapy
15) Chronic therapy with platelet function inhibitor
16) Evidence of bleeding diathesis or coagulopathy
17) Uncontrolled hypertension
18) Pregnant or lactating women, or fertile women of childbearing potential not using adequate contraception
19) Previous history of severe drug hypersensitivity
20) Any other conditions that would preclude study compliance
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetuso Ota
Organization Kanazawa University Hospital
Division name Surgery
Zip code
Address 13-1 Takara-machi, Kanazawa city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideto Fujita
Organization Kanazawa University Hospital
Division name Surgery
Zip code
Address
TEL
Homepage URL
Email hfujita@mail.kanazawa-u.ac.jp

Sponsor
Institute Dept.Surgery
Kanazawa University Hospital
Institute
Department

Funding Source
Organization Dept.Surgery
Kanazawa University Hospital
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
2009 Year 06 Month 01 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
Date of protocol fixation
2008 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2010 Year 11 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
2009 Year 05 Month 12 Day
Last modified on
2009 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002303

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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