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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006818
Receipt No. R000008062
Scientific Title A multicenter, single-arm phase II trial of bevacizumab beyond initial progression in patients treated with first-line mFOLFOX6 followed by second-line FOLFIRI in Advanced Colorectal Cancer
Date of disclosure of the study information 2011/12/01
Last modified on 2016/11/16

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Basic information
Public title A multicenter, single-arm phase II trial of bevacizumab beyond initial progression in patients treated with first-line mFOLFOX6 followed by second-line FOLFIRI in Advanced Colorectal Cancer
Acronym CCOG-0801
Scientific Title A multicenter, single-arm phase II trial of bevacizumab beyond initial progression in patients treated with first-line mFOLFOX6 followed by second-line FOLFIRI in Advanced Colorectal Cancer
Scientific Title:Acronym CCOG-0801
Region
Japan

Condition
Condition untreated and unresectable metastatic colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore the efficacy and safety of bevacizumab beyond initial progression in patients treated with first-line mFOLFOX6 followed by second-line FOLFIRI 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 2nd progression free survival (2nd PFS)
Key secondary outcomes Progression free survival (PFS),overall survival (OS), response rate (ORR), disease control rate (DCR) and safty


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 bevacizumab plus mFOLFOX6 therapy (first-line treatment)
bevacizumab plus FOLFIRI therapy (second-line treatment)
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1. Histologically confirmed colorectal adenocarcinoma.
2. Unresectable metastatic disease.
3. Age 20 to 74 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. No previous chemotherapy for mCRC.
6. Bidimensionally measurable disease.
7. A life expectancy of at least 3 months
8. Written informed consent was obtained.
9. 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-chi, Showa-ku, Nagoya, Japan
TEL 0527442250
Email goro@med.nagoya-u.ac.jp

Public contact
Name of contact person
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-chi, Showa-ku, Nagoya, Japan
TEL 0527442250
Homepage URL
Email goro@med.nagoya-u.ac.jp

Sponsor
Institute Chubu Clinical Oncology Group (CCOG)
Institute
Department

Funding Source
Organization Chubu Clinical Oncology Group (CCOG)
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 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/22886005
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 Completed
Date of protocol fixation
2008 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2013 Year 12 Month 15 Day
Date of closure to data entry
2013 Year 12 Month 15 Day
Date trial data considered complete
2013 Year 12 Month 15 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 12 Month 01 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=R000008062

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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