UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031790 |
|---|---|
| Receipt number | R000036278 |
| Scientific Title | TAS-102 and Bevacizumab as salvage line chemotherapy for colorectal cancer |
| Date of disclosure of the study information | 2018/03/20 |
| Last modified on | 2022/03/22 18:36:27 |
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Basic information
Public title
TAS-102 and Bevacizumab as salvage line chemotherapy for colorectal cancer
Acronym
SOAC1701
Scientific Title
TAS-102 and Bevacizumab as salvage line chemotherapy for colorectal cancer
Scientific Title:Acronym
SOAC1701
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the safety and efficacy of combination TAS-102 plus Bevacizumab therapy in patients with advanced/recurrent colorectal cancer who was not appropriate for intensive therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression Free Survival
Key secondary outcomes
1)Overall Survival
2)Time to Treatment Failure
3)Response Rate
4)Disease control rate
5)Adverse events
6)Relation between RAS status and effectiveness of chemotherapy
7)Relation between location of tumor and effectiveness of chemotherapy
8)Relation between the timing when chemotherapy started and effectiveness of chemotherapy
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) is administered orally twice daily in 1-5days and 15-20 days and Bevacizumab(5mg/kg) is administered by injection in day 1 and day15. 1 cycle is 28days.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patient with any of the fllowing
(1) patient who is 20 years or older, and considered to be intorelant to irinotecan or oxaliplatin.
(2) Patient who is 20 to 74 years old and with an ECOG Performance Status of 2
(3) Patient who is over 75 years old and with an ECOG Performance Status of 0 or 1
2) patient who has histologically or cytologically confirmed colorectal adenocarcinoma
3) patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s)
4) patient who has a treatment history of one or more regimens for metastatic colorectal cancer, and who is refractory or intolerant to them
5) patient who has at least one measurable lesion in imaging study
6) patient with ability to tolerate oral drug administration
7) patient who has adequate main organ functions in tests within 14 days before enrollment
(1) WBC >= 3500/mm3
(2) neutrophil count >=1,500/mm3
(3) platelet count >=75,000/mm3
(4) haemoglobin concentorarion >=9.0 g/dL
(5) AST, ALT <= 2.5x Upper limit of normal (<= 5.0x when liver metastasis exists)
(6) serum total bilirubin level <=1.5 mg/dL (<= 2.0 when liver metastasis exists)
(7) serum creatinine <=1.5 mg/dL
(8) no active infection
(9) Peripheral neuropathy<=grade2
(10) Diarrhea and NonHaematotoxicity =<grade1
8) 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) have pleural effusion and ascitic fluid with the treatment
7) previous hemoptysis (over 25ml of fresh blood)
8) current or previous (within the last 6 months) history of GI perforation
9) patient with thrombosis (within the last 6 months)
10) patient with bleeding tendency
11) synchronous or metachronous multiple malignancy within the last 5 year disease free interval
12) dicision of unsuitable for this study by the investigator
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hisahiro |
| Middle name | |
| Last name | Matsubara |
Organization
Chiba University
Division name
Department of frontier surgery
Zip code
260-8677
Address
1-8-1 Inohana, chuo-ku, Chiba-shi, Chiba, JAPAN
TEL
043-226-2109
matsuhm@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Miyauchi |
Organization
Chiba University
Division name
Department of frontier surgery
Zip code
260-8677
Address
1-8-1 Inohana, chuo-ku, Chiba-shi, Chiba, JAPAN
TEL
043-226-2109
Homepage URL
komatsuaki@office.chiba-u.jp
Sponsor or person
Institute
Surgical Oncology Association in Chiba (SOAC)
Institute
Department
Personal name
Funding Source
Organization
Department of frontier surgery, Chiba University
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
CRB
Address
1-8-1 Inohana, chuo-ku, Chiba-shi, Chiba, JAPAN
Tel
043-222-7171
shiken@office.chiba-u.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 | 20 | 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
| 2018 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 19 | Day |
Last modified on
| 2022 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036278
