UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Trial of Bevacizumab in Combination with XELOX in Colorectal Cancer Patients with Liver Metastases (H2, H3)
Title of the study (Brief title)	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	Katsuyoshi Hatakeyama
Organization	Niigata University Medical and Dental Hospital
Division name	Director of Hospital
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	Yasumasa Takii
Organization	Niigata Cancer Center Hospital
Division name	Department of Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 10 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000003534