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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001568
Receipt No. R000001888
Scientific Title Phase II trial of neoadjuvant chemotherapy with Bevacizumab plus FOLFOX6 chemotherapy for Resectable case of liver metastasis
Date of disclosure of the study information 2008/12/12
Last modified on 2015/03/09

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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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