UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022705 |
|---|---|
| Receipt number | R000025658 |
| Scientific Title | A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colorectal cancer with difficulty on intensive chemotherapy |
| Date of disclosure of the study information | 2016/06/12 |
| Last modified on | 2019/08/27 22:32:01 |
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Basic information
Public title
A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colorectal cancer with difficulty on intensive chemotherapy
Acronym
A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer
Scientific Title
A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colorectal cancer with difficulty on intensive chemotherapy
Scientific Title:Acronym
A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and toxicity of TAS-102 and bevacizumab for advanced/recurrent colorectal cancer with difficulty on intensive chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Response Rate
Disease control rate
Overall survival
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 plus bevacizumab combination therapy (q4w)
TAS-102: 35mg/m2 BID on days 1-5 and 8-12
Bevacizumab: 5mg/kg on day1 and 15
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) histologically proven colon cancer or rectal cancer (both Kras Wt and MT)
2) Group E : >= 76 years old
Group ID : >= 65 years old and with difficulty on intensive chemotherapy due to history of radiation therapy for the pelvic lesions, s-albumin lower than 3.5g/dl and/or doctors decision not to register to the other chemotherapy from intolerance to adverse events
3) with mesurable lesions for RECIST criteria
4) without any chemotherapy berore (eligible if fluoro-pyrimidine treatment has completed more than 6 months before)
5) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
6) rest period from former therapy
a) more than 4 weeks from an organ resection surgery
b) more than 4 weeks from hormone therapy or immune therapy
c) more than 4 weeks from cytokine or BRM therapy
d) more than 6 weeks from radiation therapy for extensive lesions
7) without any severe complications and limited in the following data
a) neutrophile : 1,500/mm3 <=
b) platelet : 100,000/mm3 <=
c) hemoglobin : 9.0g/dl <=
d) T.bil. : 1.5mg/dl >=
e) AST, ALT : 100 IU/l ( within 2.5 times of normal range of the hospital
f) creatinine : 1.5mg/dl >=
g) urine protein : 1+ >=
h) PT-INR : 1.5 >=
8) patients expected more than 8 weeks survival
9) able to oral intake
10) written with informed consent
Key exclusion criteria
1) with symptoms due to brain metastatis
2) with uncontrolable diarrhea
3) with difficulty on oral intake due to intestinal paralysis or obstruction
4) with infections diseases or febrile condition
5) with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc)
6) with severe diseases (uncontrollable DM, heart failure severe than NYHA lll, renal failure, and/or hepatic failure)
7) pregnant and/or nursing women, or women who expect pregnancy
8) with metastatic meningitis, uncontrollable convulsion, and/or mental disorder
9) with a condition intolerance to
medicines in this regimen
10)with a history of some chemotherapy and/or therapy including a VEGF antagonist
11) with a history of embolism, brain infraction (except Lacuna infraction) or pulmonary infraction
12) under easy bleeding condition due to some diseases or medicines (except low dose aspirin)
13) with active wounds except reservoir surgery
14) with a history of bloody spit more than 2.5ml
15) with no bowel obstruction
16) with no peritoneum disseimination
17) any other patient whom the physician in charge of the study judges to be unsuitabl
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naotoshi Sugimoto |
Organization
Osaka medical Center for Cancer and Cardiovascular Diseases
Division name
Clinical Oncology
Zip code
Address
1-3-3, Nakamichi, Higashinari-ku, Osaka
TEL
06-6972-1181
sugimoto-na2@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naotoshi Sugimoto |
Organization
Osaka medical Center for Cancer and Cardiovascular Diseases
Division name
Clinical Oncology
Zip code
Address
1-3-3, Nakamichi, Higashinari-ku, Osaka
TEL
06-6972-1181
Homepage URL
sugimoto-na2@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka medical Center for Cancer and Cardiovascular Diseases
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 12 | Day |
Last modified on
| 2019 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025658
