UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022438 |
|---|---|
| Receipt number | R000025861 |
| Scientific Title | TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2024/05/30 09:19:14 |
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Basic information
Public title
TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial
Acronym
TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial (TAS-CC3 study)
Scientific Title
TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial
Scientific Title:Acronym
TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial (TAS-CC3 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 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
Time to Treatment Failure, response rate , overall survival
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
| 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 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) atient 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
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) 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 coutinuous steroid administration
18) dicision of unsuitable for this study by the investigator
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Keiji |
| Middle name | |
| Last name | Koda |
Organization
3426-3 Anesaki, Ichihara City, Chiba 2990111, Japan
Division name
Surgery
Zip code
2990111
Address
3426-3 Anesaki, Ichihara City, Chiba 2990111, Japan
TEL
0436621211
k-koda@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamada |
Organization
Nippon medical school hospital
Division name
Gasroenterological Surgery
Zip code
1130022
Address
1-1-5 Sendagi, Bunkyo-Ku, Tokyo
TEL
03-3822-2131
Homepage URL
y-tak@nms.ac.jp
Sponsor or person
Institute
Teikyo University Chiba Medical Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Ethics Commitee, Teikyo University
Address
3426-3 Anesaki, Ichihara City, Chiba 2990111, Japan
Tel
0436-62-1211
k-koda@med.teikyo-u.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
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 |
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 24 | Day |
Last modified on
| 2024 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025861
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