UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	TAS-102 and Bevacizumab as second line chemotherapy for colorectal cancer. Phase 2 trial
Title of the study (Brief title)	TAS-102 and Bevacizumab as second line chemotherapy for colorectal cancer. Phase 2 trial (TAS-CC2 study)
Region	Japan

Condition
Condition	metastatic colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The efficacy and safety of TAS-102 plus Bevacizumab combination as second line therapy for colorectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	progression free survival
Key secondary outcomes	Time to Treatment Failure, response rate , overall survival

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	TAS-102: 35mg/m2 given orally twice a day in a 28-day cycle, 2-week cycle of 5 days treatment followed by a 2-day rest period, and then a 14-day rest period Bevacizumab: 5mg/kg given intravenously in a 2-week cycle
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically proven colorectal cancer 2) patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s) 3) treatment history of one regimens for metastatic colorectal cancer, and who has confirmed PD in imaging study 4) 20<= and 80>= years old 5) ECOG performance status of 0 or 1 6) With measurable lesions according 7) ability to tolerate oral drug administration 8) standard second therapy not eligibility 9) a life expectancy of at least 3 months 10) Patient who has adequate main organ functions in tests within 14 days before enrollment leukocyte >=3,500/mm3 neutrophil >=1,500/mm3 platelet >=75,000/mm3 haemoglobin concentorarion >=8.0 g/dL serum total bilirubin level <=1.5 mg/dL serum creatinine <=1.5 mg/dL serum AST and ALT levels <2.5x Upper limit of normal (ULN). serum creatinine <=1.5 mg/dL Peripheral neuropathy<=grade2 Diarrhea and NonHaematotoxicity =<grade1 11) gave written informed consent
Key exclusion criteria	1) contraindications for TAS-102 and Bevacizumab 2) previously received chemotherapy with TAS-102 3) severe drug allergy 4) pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy. 5) patient who has important clinical complications (symptomatic unstable ischemic heart disease, arrhythmia, acute myocardial infarction within 6 months, liver cirrhosis, renal failure, active gastrointestinal ulcer, ileus, uncontrolled diabetes, uncontrolled hypertension, etc.) 6) other active malignancies 7) have pleural effusion and ascitic fluid with the treatment 8) Comorbidity or history of heart failure 9) gastrointestinal ulcer or bleeding 10) previous hemoptysis 11) Peritoneal metastases at image 12) Clinical or radiological evidence of CNS metastases 13) Current or previous (within the last 6 months) history of GI perforation 14) Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study 15) ongoing treatment with anticoagulant 16) Synchronous or metachronous multiple malignancy within the last 5 year disease free interval 17) Under continuous steroid administration 18) decision of unsuitable for this study by the investigator
Target sample size	20

Research contact person
Name of lead principal investigator	Keiji Koda
Organization	Teikyo University Chiba Medical Center
Division name	Surgery
Address	3426-3 Anesaki, Ichihara City, Chiba 2990111, Japan
TEL	0436621211
Email	k-koda@med.teikyo-u.ac.jp

Public contact
Name of contact person	Takeshi Yamada
Organization	Nippon medical school hospital
Division name	Digestive Surgery
Address	1-1-5 Sendagi, Bunkyo-Ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	y-tak@nms.ac.jp

Sponsor
Institute	Teikyo University Chiba Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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	帝京大学ちば総合医療センター 日本医科大学付属病院

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 05 Month 18 Day
Anticipated trial start date	2016 Year 06 Month 01 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	2016 Year 05 Month 24 Day
Last modified on	2016 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025859