UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of TS-1+Irinotecan+Bevacizumab as second-line treatment in patients with metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy
Title of the study (Brief title)	JACCRO CC-07 study
Region	Japan

Condition
Condition	Metastatic 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 TS-1+irinotecan+bevacizumab as second-line treatment in metastatic colorectal cancer refractory to fluonated pyrimidine, oxaliplatin, and cetuximab therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	6-Month Progression Free Survival Rate
Key secondary outcomes	Overall Survival Progression Free Survival Response Rate 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	TS-1+Irinotecan+Bevacizumab therapy Bevacizumab 7.5mg/m2/tri-weekly Irinotecan 150mg/m2/tri-weekly TS-1 80-120mg/day, for 14 days followed by 1 week rest
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)Patients with histologically proven colorectal cancer (2)Metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy as first-line (3)Presence of evaluable lesion (4)ECOG Performance Status 0-1 (5)Age equal more 20 years old (6)Life expectancy of more than 3 months (7)Oral food intake possible (8)Patiens have enough organ function for study treatment within 14 days before enrollment WBC>=3,000/mm3, <12,000/mm3 Neu>=1,500/mm3 PLT>=10.0x104/mm3 Hb>=9.0g./dL Total Bilirubin <= 1.5mg/dL AST<=100 IU/L ALT<=100 IU/L Creatinine <=1.2mg/dL Creatinine clearance >=50mL/min Proteinuria<=2+ PT-INR <=1.5 (9)Written informed consent
Key exclusion criteria	(1)Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval (2)Symptomatic brain metastases (3)Infectious disease (4)Interstitial lung disease or pulmonary fibrosis (5)Comorbidity or history of heart failure (6)History of thromboembolic events (7)History of hemoptysis (8)Sensory alteration or paresthesia interfering with function (9)Large quantity of pleural, abdominal or cardiac effusion (10)Severe comorbidity (renal failure, liver failure, hypertension, etc) (11)Prior radiotherapy for primary and metastases tumors (12)Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breast feeding. Women with a positive pregnancy test (13)History of severe allergy (14)Surgical procedure or such as skin-open biopy, trauma surgery, or other more intensive surgeries within 4 weeks (15)Systemic administration of antiplatelet drug or NSAIDs (16)Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy (17)Uncontrolled peptic ulcer (18)History of gastrointestinal perforation within 1 year (19)Untreated traumatic bone fracture (20)Require treatment of renal dysfunction (21)Doubting dihydropyrimidine dehydrogenase deficit (22) Uncontrolled diarrhea (23)History of organ recipient (24)Administration of atazanavir sulfate (25Administration of flucytosine (26)Jaundice (27) Ileus or bowel obstruction (28)Any other cases who are regarded as inadequate for study enrollment by investigators
Target sample size	70

Research contact person
Name of lead principal investigator	Ken Shimada
Organization	Showa University Koto Toyosu Hospital
Division name	Department of Internal Medicine
Address	5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan
TEL	03-6204-6000
Email	shimakenken60@hotmail.com

Public contact
Name of contact person	Masashi Fujii
Organization	Japan Clinical Cancer Research Organization
Division name	Office
Address	7F, 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL	03-5579-9882
Homepage URL
Email	cc07.dc@jaccro.or.jp

Sponsor
Institute	Japan Clinical Cancer Research Organization
Institute
Department

Funding Source
Organization	Japan Clinical Cancer Research Organization
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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 03 Month 26 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 03 Month 06 Day
Anticipated trial start date	2013 Year 03 Month 06 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 26 Day
Last modified on	2016 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012078