UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002897 |
|---|---|
| Receipt number | R000003534 |
| Scientific Title | Phase II Trial of Bevacizumab in Combination with XELOX in Colorectal Cancer Patients with Liver Metastases (H2, H3) |
| Date of disclosure of the study information | 2009/12/15 |
| Last modified on | 2019/02/03 21:25:17 |
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Basic information
Public title
Phase II Trial of Bevacizumab in Combination with XELOX in Colorectal Cancer Patients with Liver Metastases (H2, H3)
Acronym
NCCSG-05
Scientific Title
Phase II Trial of Bevacizumab in Combination with XELOX in Colorectal Cancer Patients with Liver Metastases (H2, H3)
Scientific Title:Acronym
NCCSG-05
Region
| Japan |
Condition
Condition
colorectal liver metastases
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and/or safety of bevacizumab in combination with XELOX (a maximum of 9 cycles) for the purpose ofliver resection in colorectal cancer patients with liver metastases (H2, H3)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
resection rate of liver metastases
Key secondary outcomes
R0 resection rate of liver metastases, overall response rate, progression free survival, relapse free survival, overall survival, adverse events, sinusoidal injury
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 3 weeks until evidence of progression, unacceptable toxicity, patient refusal, or for a maximum of 9 cycles.
During the treatment, image assessment is repeated every 3 cycles, and if liver metastases could be converted resectable, liver resection is performed.
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.colorectal cancer, cytologically and/or histrogically
2.synchronous or metachronous liver metastases
*no prior treatment for liver metastases
3.no extra hepatic metastases
4.age: 20-79 years old
5.ECOG PS: 0-1
6.sufficient organ functions
7.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 prior to Day 0
4.serious non-healing fracture
5.current or previous (within the last 1 year) history of GI perforation
6.serious non-healing ulcer
7.evidence of bleeding diathesis or coagulopathy.
8.current or recent (within 10 days prior to enrllment) ongoing treatment with anticoagulants for therapeutic purposes
9.ongoing treatment with aspirin (> 325 mg/day)
10.clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) 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. neuropathy >= Grade 1 according to the Common Toxicity Criteria of the National Cancer Institute, version 3.
16.interstitial lung disease, or pulmonary fibrosis
17. diarrhea >= Grade 2 according to the Common Toxicity Criteria of the National Cancer Institute, version 3.
18.uncontrolled infection
19.history of organ transplantation
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.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
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuyoshi Hatakeyama |
Organization
Niigata University Medical and Dental Hospital
Division name
Director of Hospital
Zip code
Address
Asahimachi-dori 1-754, Chuo-ku, Niigata, 951-8520
TEL
025-223-6161
takii@niigata-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasumasa Takii |
Organization
Niigata Cancer Center Hospital
Division name
Department of Surgery
Zip code
Address
Kawagishi-cho 2-15-3, Chuo-ku, Niigata, 951-8566
TEL
025-266-5111
Homepage URL
takii@niigata-cc.jp
Sponsor or person
Institute
Niigata Colorectal cancer
Chemotherapy Study Group (NCCSG)
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Niigata Colorectal cancer
Chemotherapy Study Group (NCCSG)
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 | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 15 | Day |
Last modified on
| 2019 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003534
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| Registered date | File name |
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