UMIN-CTR Clinical Trial

Basic information
Public title	TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial
Acronym	TAS-CC4 Study
Scientific Title	TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial
Scientific Title:Acronym	TAS-CC4 Study
Region	Japan

Condition
Condition	metastatic colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The efficacy and safety of TAS-102 plus Bevacizumab combination (5-day treatment followed by a 9-day rest period) as third 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	Response rate , overall survival, Safety, and incidence of Grade 3 neutropenia

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 daily on days 1-5 and 15-19 in a 28-day cycle. 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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
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 two or more 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)a life expectancy of at least 3 months 9)Patient who has adequate main organ functions in tests within 14 days beforeenrollment 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/dLserum 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 10)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)Clinical or radiological evidence of CNS metastases 12)Current or previous (within the last 6 months) history of GI perforation 13)Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study 14)ongoing treatment with anticoagulant 15)Synchronous or metachronous multiple malignancy within the last 5 year disease free interval 16)Under continuous steroid administration 17)decision of unsuitable for this study by the investigator
Target sample size	45

Research contact person
Last name of lead principal investigator	1st name Takeshi Middle name Last name Yamada
Organization	Nippon Medical School
Division name	Digestive Surgery
Zip code	113-8602
Address	1-1-5 Sendagi, Bunkyo-Ku, Tokyo, Japan
TEL	03-3822-2131
Email	y-tak@nms.ac.jp

Public contact
1st name of contact person	1st name Takeshi Middle name Last name Yamada
Organization	Nippon Medical School
Division name	Digestive Surgery
Zip code	113-8602
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL	03-3822-2131
Homepage URL
Email	y-tak@nms.ac.jp

Sponsor
Institute	Department of Digestive Surgery,Nippon Medical School
Institute
Department

Funding Source
Organization	Department of Digestive Surgery, Nippon Medical School
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	q
Address	q
Tel	03-3822-2131
Email	clinicaltrial@nms.ac.jp

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	2018 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
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	Enrolling by invitation
Date of protocol fixation	2018 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 11 Month 18 Day
Last modified on	2019 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034286