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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000006478
Receipt No. R000007690
Scientific Title Multicenter Phese II Study of Optimal-XELOX plus Bevacizumab Therapy with Oxaliplatin Stop-and-Go Strategy and Oral capecitabin plus Bevacizumab Maintenance Therapy in Advanced Colorectal Cancer
Date of disclosure of the study information 2011/10/05
Last modified on 2016/11/16

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Basic information
Public title Multicenter Phese II Study of Optimal-XELOX plus Bevacizumab Therapy with Oxaliplatin Stop-and-Go Strategy and Oral capecitabin plus Bevacizumab Maintenance Therapy in Advanced Colorectal Cancer
Acronym Phese II Study of Optimal-XELOX plus Bevacizumab Therapy in Advanced Colorectal Cancer (CCOG-0902 Study)
Scientific Title Multicenter Phese II Study of Optimal-XELOX plus Bevacizumab Therapy with Oxaliplatin Stop-and-Go Strategy and Oral capecitabin plus Bevacizumab Maintenance Therapy in Advanced Colorectal Cancer
Scientific Title:Acronym Phese II Study of Optimal-XELOX plus Bevacizumab Therapy in Advanced Colorectal Cancer (CCOG-0902 Study)
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of optimal-XELOX plus bevacizumab therapy considering Oxaliplatin Stop-and-Go Strategy in 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
Key secondary outcomes Overall response rate, Overall survival, Duration of disease control, Reintroduction rate of XELOX+bavacizumab therapy, Safety

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 (1)Initial therapy
: XELOX+bevacizumab therapy
(2)Maintenance therapy
: capecitabine+bevacizumab therapy
(3)Reintroduced therapy
: XELOX+bevacizumab therapy
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) Histopathologically confirmed colorectal cancer.
(2) Written informed consent.
(3) Age of 20 years or older.
(4) ECOG performance status 0-1.
(5) Life expectancy greater than 3 months.
(6) Measurable or evaluable disease (RECIST ver.1.1.).
(7) Untreated colorectal cancer.
(8) Adequate organ function.
Key exclusion criteria (1) Previous history of severe drug-induced allergy
(2) Brain metastasis
(3) Cerebrovascular disease or its symptoms within 1 year.
(4) Massive pleural effusion or ascites that required drainage.
(5) History of active double cancer.
(6) Previous history of thoromboembolitic disease, or necessity for antithrombotic drug.
(7) Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer.
(8) History of gastrointestinal perforation within 1 year.
(9) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy.
(10) Severe renal failure or urinary protein (more than 2+).
(11) Uncontrolled severe complications (DM, hypertension, diarrhea, et al.).
(12) 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.
(13) Interstitial lung disease or pulmonary fibrosis.
(14) Uncontrolled infection.
(15) 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.
(16) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
(17) 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 Goro Nakayama
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan
TEL 052-744-2253
Email goro@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miyuki Aoki
Organization Chubu Clinical Oncology Group (CCOG)
Division name Data Center
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan
TEL (81)52-744-2253
Homepage URL http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/
Email goro@med.nagoya-u.ac.jp

Sponsor
Institute Chubu Clinical Oncology Group (CCOG)
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially 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 Main results already published
Date of protocol fixation
2010 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2015 Year 09 Month 15 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2016 Year 05 Month 06 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 05 Day
Last modified on
2016 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007690

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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