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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021664
Receipt No. R000024979
Scientific Title TAS-102 plus Bevacizumab combination as salvage therapy in elderly patients with metastatic colorectal cancer, phase 2 trial
Date of disclosure of the study information 2016/04/26
Last modified on 2016/03/29

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Basic information
Public title TAS-102 plus Bevacizumab combination as salvage therapy in elderly patients with metastatic colorectal cancer, phase 2 trial
Acronym TAS-102 plus Bevacizumab as salvage therapy in elderly patients with metastatic colorectal cancer
Scientific Title TAS-102 plus Bevacizumab combination as salvage therapy in elderly patients with metastatic colorectal cancer, phase 2 trial
Scientific Title:Acronym TAS-102 plus Bevacizumab as salvage therapy in elderly patients with metastatic colorectal cancer
Region
Japan

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

Objectives
Narrative objectives1 The efficacy and safety of TAS-102 plus Bevacizumab combination as salvage therapy in elderly metastatic colorectal cancer patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes overall survival
Key secondary outcomes progression free survival, response rate , disease control rate, relative dose intensity, frequency and grade of adverse events

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

Eligibility
Age-lower limit
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) patient who has histologically or cytologically confirmed colorectal adenocarcinoma
2) patient who has confirmed K-RAS status of colorectal cancer
3) patient who has a treatment history of one or more regimens for metastatic colorectal cancer, and who is refractory or intolerant to them
4) patient who has at least one measurable lesion in imaging study within 28 days before enrollment(not essential criteria)
5) patient who is 70 years or older, and considered to be intorelant to other strong chemotherapeutic regimens after one or more strong regimens
6) patient with an ECOG Performance Status of between 0 and 2
7) patient with ability to tolerate oral drug administration
8) patient who has adequate main organ functions in tests within 14 days before enrollment
neutrophil count >=1,500/mm3
platelet count >=100,000/mm3
haemoglobin concentorarion >=9.0 g/dL
serum total bilirubin level <=1.5 mg/dL
serum AST and ALT levels <=100 U/L
serum creatinine <=1.5 mg/dL
9) patient who has a life expectancy of at least 3 months
10) written informed consent got from the patient
Key exclusion criteria 1) patient who had previously received chemotherapy with TAS-102
2) patient who has history of hemoptysis(>=25mL, fresh blood)
3) patient with other active malignancies
4) patient with symptomatic brain metastasis
5) patients with serious pleural effusion, ascites or pericardial effusion
6) patients with active infection
7) Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study
8) 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.)
9) patient with non-healing wound or traumatic bone fracture
10) patient with bleeding disorders or current use of anticoagulant
11) patient with severe drug allergy
12) male patient who hoping partner's pregnancy
13) patient who has at least either one of HIV antibody, HBs antigen, or HCV antibody
14) patient who given a dicision of unsuitable for this study by the investigator
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuji Takayama
Organization Tokushima University Hospital
Division name Gastroenterology and Oncology
Zip code
Address 2-50-1 Kuramoto Tokushima-City Tokushima, Japan
TEL 088-633-7124
Email takayama@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuji Takayama
Organization Institute of Biomedical Sciences, Tokushima University Graduate School
Division name Gastroenterology and Oncology
Zip code
Address 3-18-15 Kuramoto Tokushima-city, Tokushima Japan
TEL 088-633-7124
Homepage URL
Email takayama@tokushima-u.ac.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 徳島大学病院(徳島県)
国立病院機構北海道がんセンター(北海道)
斗南病院(北海道)
小樽掖済会病院(北海道)
製鉄記念室蘭病院(北海道)
徳島赤十字病院(徳島県)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 26 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 Preinitiation
Date of protocol fixation
2016 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 26 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
2016 Year 03 Month 29 Day
Last modified on
2016 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024979

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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