UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of XELOX plus bevacizumab as second-line chemotherapy prior oral fluoropyrimidine, irinotecan plus bevacizmab for metastatic colorectal cancer
Title of the study (Brief title)	CCOG 1203
Region	Japan

Condition
Condition	Unresectable metastatic or recurrent colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of XELOX plus bevacizumab as second-line chemotherapy for unresectable metastatic or recurrent colorectal cancer patients who have failed prior oral fluoropyrimidine, irinotecan plus bevacizumab
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	ORR;Over response rate
Key secondary outcomes	Progression free survival, Duration of disease control, Time to treatment-failure, Overall survival, Safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	XELOX plus bevacizumab therapy Bevacizumab 7.5mg/kg day1 Oxaliplatin 130mg/m2 day1 Capecitabin 2000mg/m2/day day1-15
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 patient who have failed prior oral fluoropyrimidine , irinotecan plus bevacizumab (3)Age of 20 years or older (4)ECOG performance status 0-1 (5)Measurable or evaluable disease (RECIST ver.1.1.) (6)Alife expectancy greater than 3 months (7)satisfactory oral feeding (8)Adequate organ function (9)Written informed concent
Key exclusion criteria	1)Uncontrolled infection. 2)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated 3)Previous history of thoromboembolitic disease,or necessity for antithrombotic drug. 4)Severe lung disease.(Interstitial lung disease or pulmonary fibrosis.) 5)Severe liver disease. 6)Severe renal failure. 7)Previous history of severe drug-induced allergy 8)Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer. 9)History of gastrointestinal perforation within 1 year. 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)Patients with psycho-neurological disease,central nervous system damage,cerebrovascular disorder 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)Patient with untreated traumatic bone fracture. 17)Diathesis of bleeding (history of hemoptysis,including cavitation and/or necrosis in lung metastasis confirmed by imaging),coagulopathy. 18) Systemic administration of antiplatelet drug 19)Administration of immunosuppressants associated with organ transplantation 20)Patient who have peripheral nerve disorder 21)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. 22)Previous history of severe side effects for fluoropyrimidine 23)Not appropriate for the study at the physician's assessment
Target sample size	25

Research contact person
Name of lead principal investigator	Goro Nakayama
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology
Address	65 Tsurumai-cho Showa-ku Nagoya-city Aichi Japan
TEL	(81)52-744-2253
Email	goro@med.nagoya-u.ac.jp

Public contact
Name of contact person	Miyuki Aoki
Organization	Clinical Oncology Group(CCOG)
Division name	Data Center
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	norifumi@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)

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	2013 Year 08 Month 22 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 04 Month 01 Day
Anticipated trial start date	2012 Year 04 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 08 Month 22 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=R000013517