UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001568 |
|---|---|
| Receipt number | 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 08:49:26 |
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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
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
kein_h11@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Miyagi HBPCOG
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001888
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| Registered date | File name |
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