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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005732
Receipt No. R000006695
Scientific Title Assessment of clinical efficacy and safety in capecitabine plus intermittent oxaliplatin (intermittent CapeOx)together with Bevacizumab as the first-line therapy for patients with advanced colorectal cancer; multicenter phase II trial
Date of disclosure of the study information 2011/06/07
Last modified on 2011/06/07

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Basic information
Public title Assessment of clinical efficacy and safety in capecitabine plus intermittent oxaliplatin (intermittent CapeOx)together with Bevacizumab as the first-line therapy for patients with advanced colorectal cancer; multicenter phase II trial
Acronym Phase II clinical trial using capecitabine plus intermittent oxaliplatin together with Bevacizumab for the treatment of patients with advanced colorectal cancer (VOICE trial)
Scientific Title Assessment of clinical efficacy and safety in capecitabine plus intermittent oxaliplatin (intermittent CapeOx)together with Bevacizumab as the first-line therapy for patients with advanced colorectal cancer; multicenter phase II trial
Scientific Title:Acronym Phase II clinical trial using capecitabine plus intermittent oxaliplatin together with Bevacizumab for the treatment of patients with advanced colorectal cancer (VOICE trial)
Region
Japan

Condition
Condition advanced colorectal cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To access the efficacy and safety of the combination of intermittent CapeOx + Bevacizumab as a first-line therapy in patients with advanced colorectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes progression free survival (PFS)
Key secondary outcomes Safety
time-to-treatment failure
response rate 1 (RR 1)
progression free survival 2 (PFS 2)
response rate 2 (RR 2)
resection rate in

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 capecitabine plus intermittent oxaliplatin (CapeOx) in combination with Bevacizumab: (CapeOx + Bevacizumab)x5 cycles followed by (Capecitabine + Bevacizumab )x5 cycles, followed by (CapeOx + Bevacizumab)x5 cycles are administered until progression.

[CapeOx + Bevacizumab]
Capecitabine: 2000mg/m2/day p.o. (day1-15)
Oxaliplatin: 130mg/m2 i.v. (day1)
Bevacizumab: 7.5mg/kg i.v. (day1)
to be repeated every 3 weeks


[Capecitabine + Bevacizumab]
Capecitabine: 2000mg/m2/day p.o. (day1-15)
Bevacizumab: 7.5mg/kg i.v. (day1)
to be repeated every 3 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria (1)Written informed consent.
(2)20 years old or more when received informed consent.
(3)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):0-1.
(4)Life expectancy estimated 3 months, and more.
(5)Histological confirmation of colorectal cancer.
(6)With estimative lesion observed in imaging or intraoperation within 28 days before registration. (measurable lesions in RECIST criteria [ver.1.1] is dispensable)
(7)Patients with metastatic colorectal cancer who had recieved no previous therapy.
Patients with advanced colorectal cancer who had received no intervention expect surgical procedure.
Patients with recurrent colorectal cancer who have not been administered any therapy to the recurrent site.
(8)Patients who received no previous chemotherapy
i.Patients who administered curative resection for primary or metastatic site with perioperative chemotherapy is excluded.
ii.Patients who received non-curative resection is included.
iii.Previous treatment with oxaliplatin contained regimen is allowed if it is completed at least 6 months before registration.
(9)Vital organ functions (listed below) are preserved within 14 days prior to entry.
i.White blood cell count >= 3,000/mm3
ii.Neutrophils >= 1,500/mm3
iii.Platelets >= 100,000/mm3
iv.Hemoglobin >= 9.0 g/dL
v.Total bilirubin <= upper limit of normal (ULN)*1.5
vi.AST and ALT <= upper limit of normal (ULN)*2.5
(<= ULN*5 in case of liver metastasis)
vii.Serum creatinine <= upper limit of normal (ULN)*1.5
viii.Urinary protein <= grade1 (+1)
Key exclusion criteria (1)History of the severe hypersensitivity for capecitabine, oxaliplatin or bevacizumab.
(2)CNS metastases or brain cancer confirmed by imaging.
(3)Cerebrovascular disease or its symptoms within 1 year. Prior abdominal irradiation for colorectal cancer. History of suspected complication of arterial thromboembolism such as cerebrovascular disease or experienced thromboembolism once within a year or twice bore.
(4)History of gastrointestinal perforation within 1 year.
(5)Synchronous malignant coelomic fluid that required drainage.
(6)Uncontrolled peptic ulcer.
(7)Uncontrolled diarrhea.
(8)Uncontrolled infection.
(9)Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy or abnormality of coagulation factor as INR>=1.5.
(10)Uncontrolled hypertension.
(11)Necessity for antithrombotic drug or drugs affected to coagulation and fibrinolytic system within 14 days before enrollment(Expect for low-dose of aspirin).
(12)History of active double cancer within 5 years.
(13)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
(14)Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week.
(15)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year.
(16)Not appropriate for the study at the physician's assessment.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiji Koda
Organization Teikyo University Chiba Medical Center
Division name Department of Surgery
Zip code
Address 3426-3 Anesaki, Ichihara City, 2990111 Japan
TEL 0436-62-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chihiro Kosugi and Toru Tezuka
Organization Teikyo University Chiba Medical Center
Division name Department of Surgery
Zip code
Address 3426-3 Anesaki, Ichihara City, 2990111 Japan
TEL 043-293-0086
Homepage URL
Email ckosugi0126@yahoo.co.jp

Sponsor
Institute Surgical Oncology Association in Chiba (SOAC)
Institute
Department

Funding Source
Organization Surgical Oncology Association in Chiba (SOAC)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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
プロトコール委員会
帝京大学ちば総合医療センター 外科
千葉大学医学部 先端応用外科学
東邦大学医療センター佐倉病院 外科
成田日赤病院 外科
君津中央病院 外科
聖隷佐倉市民病院 外科
千葉県がんセンター 消化器内科
亀田総合病院 腫瘍内科
船橋中央病院 外科
船橋市立医療センター 外科

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 07 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
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2015 Year 03 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 06 Month 07 Day
Last modified on
2011 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006695

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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