UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001961 |
|---|---|
| Receipt number | 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 22:40:32 |
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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
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
hfujita@mail.kanazawa-u.ac.jp
Sponsor or person
Institute
Dept.Surgery
Kanazawa University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002303
