UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005732
Receipt number 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 10:33:54

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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 or person

Institute

Surgical Oncology Association in Chiba (SOAC)

Institute

Department

Personal name



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

Value
https://center6.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