UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005413 |
|---|---|
| Receipt number | R000001867 |
| Scientific Title | Phase I/II Trial of Bevacizumab in Combination With FOLFOXIRI As First-Line Therapy in Colorectal Cancer Patients With Liver Metastases |
| Date of disclosure of the study information | 2011/04/08 |
| Last modified on | 2011/04/08 19:26:13 |
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Basic information
Public title
Phase I/II Trial of Bevacizumab in Combination With FOLFOXIRI As First-Line Therapy in Colorectal Cancer Patients With Liver Metastases
Acronym
Phase I/II trial of mFOLFOXIRI+Bev for liver metastases of colorectal cancer
Scientific Title
Phase I/II Trial of Bevacizumab in Combination With FOLFOXIRI As First-Line Therapy in Colorectal Cancer Patients With Liver Metastases
Scientific Title:Acronym
Phase I/II trial of mFOLFOXIRI+Bev for liver metastases of colorectal cancer
Region
| Japan |
Condition
Condition
colorectal cancer patients with fore or more liver metastases
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the maximum-tolerated dose and/or the recommended doses and to assess the efficacy and/or safety of bevacizumab in combination with a biweekly chemotherapy regimen with irinotecan, oxaliplatin, infusional fluorouracil, and levofolonate as first-line therapy in colorectal cancer patients with fore or more liver metastases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
RD (phase I)
Resection rate of liver metastases (phase II)
Key secondary outcomes
safety, the rate of R0 resection of liver metastases, overall response rate, TTF, PFS, RFS, OS
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
Treatment is administered every 2 weeks until evidence of DLT, progression, unacceptable toxicity, patient refusal, or for a maximum of 2 cycles to assess the feasibility. (phase I)
Treatment is administered every 2 weeks until evidence of progression, unacceptable toxicity, patient refusal, or for a maximum of 6 cycles to assess the rate of resection of liver metastases achieved after treatment with 6 cycles. (phase II)
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed colorectal cancer.
2. Evaluable synchronous colorectal liver metastases or metachronous liver metastases
*no prior treatment for liver metastases
3. Four or more liver metastases
4. No extra hepatic metastases
5. Age: 20-74 years old
6. ECOG PS: 0-1
7. Sufficient organ functions
8. Life expectancy estimated >= 3 months
9. Written informed consents
Key exclusion criteria
1. Clinical or radiological evidence of CNS metastases.
2. Current or previous (within the last 1 year) history of cerebrovascular disease
3. Major surgical procedure, open biopsy or significant traumatic injury except for CV-port procedure within 28 days
4. Non-healing fracture
5. Current or previous (within the last 1 year) history of GI perforation
6. Non-healing ulcer
7. Bleeding diathesis or coagulopathy.
8. Current or recent (within 10 days ) treatment with anticoagulants for therapeutic purposes
9. Ongoing treatment with aspirin
10. Clinically significant (i.e. active) cardiovascular disease, or past or current history of myocardial infarction
11. Uncontrolled hypertension
12. Serious renal failure, 1+ or higher proteinuria within 2 weeks prior to enrollment
13. Uncontrolled pleural and/or peritoneal effusion
14. Past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated:- Basal and squamous cell carcinoma of the skin, - In-situ carcinoma of the cervix
15. Interstitial lung disease, or pulmonary fibrosis
16. Uncontrolled infection
17. History of organ transplantation
18. Neuropathy >= Grade 1 according to the Common Toxicity Criteria of the National Cancer Institute, version 3.
19. Diarrhea >= Grade 2
20. Pregnancy (positive serum pregnancy test) and lactation
21. Serious drug hypersensitivity or a history of drug allergy
22. History of adverse events related to fluorouracil
23. Participation in another investigational study within 4 weeks prior to enrollment
24. Bevacizumab, oxaliplatin and/or irinotecan used previous chemotherapy, fluorouracil based adjuvant chemotherapy within 6 months prior to enrollment
25. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Ichikawa |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Clinical Oncology
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama, 236-0004
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Clinical Oncology
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama, 236-0004
TEL
Homepage URL
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University School of Medicine
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
| 2011 | Year | 04 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | 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
| 2011 | Year | 04 | Month | 08 | Day |
Last modified on
| 2011 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001867
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