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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030030
Receipt No. R000034286
Scientific Title TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial
Date of disclosure of the study information 2018/03/01
Last modified on 2019/05/21

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000034286

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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