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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006476
Receipt No. R000007687
Scientific Title Multicenter phase II study of adding bevacizumab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Date of disclosure of the study information 2011/10/06
Last modified on 2016/11/16

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Basic information
Public title Multicenter phase II study of adding bevacizumab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Acronym Phase II study of S-1 plus bevacizumab as the third-line therapy in advanced colorectal cancer (CCOG-1105; C3-03 study)
Scientific Title Multicenter phase II study of adding bevacizumab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Scientific Title:Acronym Phase II study of S-1 plus bevacizumab as the third-line therapy in advanced colorectal cancer (CCOG-1105; C3-03 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 oral S-1 plus bevacizumab therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies.
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 One year survival rate, Overall survival, Response rate, Disease control rate, Time to treatment failure, Toxicity

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 S-1 plus 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) Unresectable advanced colorectal cancer patients who have failed prior oxaliplatin- and irinotecan-based therapies with bevacizumab.
(3) Measurable or evaluable disease (RECIST ver.1.1.).
(4) Colorectal cancer with Kras mutant type gene.
(5) Age of 20 years or older.
(6) ECOG performance status 0-1.
(7) Life expectancy greater than 3 months.
(8) Written informed concent.
(9) Adequate organ function.
Key exclusion criteria (1) Uncontrolled infection.
(2) 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.
(3) Previous history of thoromboembolitic disease, or necessity for antithrombotic drug.
(4) Severe lung disease.
(5) Interstitial lung disease or pulmonary fibrosis.
(6) Severe liver disease.
(7) Severe renal failure, or urinary protein (more than 2+).
(8) Previous history of severe drug-induced allergy
(9) Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer.
(10) Uncontrolled severe complications (DM, hypertension, diarrhea, et al.).
(11) History of active double cancer.
(12) Massive pleural effusion or ascites that required drainage.
(13) Brain metastasis
(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) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy.
(16) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
(17) Not appropriate for the s
Target sample size 30

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 Takahiro Asada, Koji Torii
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 (81)52-744-2250
Homepage URL http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/
Email goro@med.nagoya-u.ac.jp

Sponsor
Institute Cubu 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 06 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 Enrolling by invitation
Date of protocol fixation
2011 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 10 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
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=R000007687

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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