UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020240 |
|---|---|
| Receipt number | R000023311 |
| Scientific Title | TAS-102 plus Bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer, phase 2 trial |
| Date of disclosure of the study information | 2016/01/26 |
| Last modified on | 2015/12/17 10:36:28 |
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Basic information
Public title
TAS-102 plus Bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer, phase 2 trial
Acronym
TAS-102 plus Bevacizumab in elderly patients with metastatic colorectal cancer
Scientific Title
TAS-102 plus Bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer, phase 2 trial
Scientific Title:Acronym
TAS-102 plus Bevacizumab in elderly patients with metastatic colorectal cancer
Region
| Japan |
Condition
Condition
metastaic colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the safety and efficacy of TAS-102 plus Bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
relative dose intensity
Key secondary outcomes
overall survival, progression free survival, response rate, disease control rate, 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 no previous chemotherapeutic history for metastatic colorectal cancer
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 strong chemotherapeutic 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:>=9.0g/dL
serum total bilirubin level:<=1.5mg/dL
serum AST and ALT levels:<=100U/L
serum creatinine:<=1.5mg/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 has chemotherapeutic history for colorectal cancer
2) patient who has history of hemoptysis(>=25mL, fresh blood)
3) patient with other active malignancies
4) patient with symptomatic brain metastasis
5) patient with serious pleural effusion, ascites or pericardial effusion
6) patient 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 hoping partner's pregnancy
13) patient who has at least either one of HIV antibody, HBs antigen, or HCV antibody
14) patient given a dicision of unsuitable for this study by the investigator
Target sample size
30
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
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
takayama@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | 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 | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | 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
| 2015 | Year | 12 | Month | 17 | Day |
Last modified on
| 2015 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023311
