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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002897
Receipt No. 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

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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
Email 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
Email takii@niigata-cc.jp

Sponsor
Institute Niigata Colorectal cancer
Chemotherapy Study Group (NCCSG)
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003534

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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