UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Goro Nakayama
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Address	65 Tsurumai-chi, Showa-ku, Nagoya, Japan
TEL	0527442250
Email	goro@med.nagoya-u.ac.jp

Public contact
Name of contact person	Goro Nakayama
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 05 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/22886005
Results
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/icdr_e/ctr_view.cgi?recptno=R000008062