UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013945 |
|---|---|
| Receipt number | R000016253 |
| Scientific Title | TS-1+ Oxaliplatin+ Bevacizumab therapy in consideration of OPTIMOX design for metastatic colorectal cancer |
| Date of disclosure of the study information | 2014/05/13 |
| Last modified on | 2014/05/13 14:51:03 |
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Basic information
Public title
TS-1+ Oxaliplatin+ Bevacizumab therapy in consideration of OPTIMOX design for metastatic colorectal cancer
Acronym
SABMOX study
Scientific Title
TS-1+ Oxaliplatin+ Bevacizumab therapy in consideration of OPTIMOX design for metastatic colorectal cancer
Scientific Title:Acronym
SABMOX study
Region
| Japan |
Condition
Condition
metastatic colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of TS-1+ Oxaliplatin+ Bevacizumab therapy in consideration of OPTIMOX design for metastatic colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DDC ; Duration of disease control
Key secondary outcomes
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
TS-1+ Oxaliplatin+ Bevacizumab/TS-1+ Bevacizumab
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. Age :<=20 years
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
3. Histological confirmation of colorectal cancer.
4. No prior chemotherapy except adjuvant chemotherapy if completed more than 6months prior to enrollment.
5. Measurable or evaluable disease. (RECIST 1.1)
6. survival more than 3 months.
7. Vital organ functions (listed below) are preserved within 2 weeks prior to entry.
8. Written informed consent.
Key exclusion criteria
1. Need to drain malignant fluid.
2. With a history of allergic response to Fluorouracil or Levofolinate calcium or Platinium.
3. Pregnant or lactating women or women of childbearing potential.
4. Uncontrolled infection.
5. Evidence of interstinal lung disease, or pulmonary fibrosis.
6. Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction.
7. Uncontrollable ulcer indigestive tract.
8. Radiological evidence of CNS metastases or brain cancer.
9. Complication of cerebrovascular disease or symptoms within 1 year.
10. Any surgical treatments within 4 weeks.
11. Administering antithrombotic drug within 10 days. Need to administrate or having anti-platelets therapy
12. Multiple primary cancers within 5 years.
13. Other conditions not suitable for this study.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Sato |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Medical Oncology and Hematology
Zip code
Address
S-1,W-16,Sapporo
TEL
011-611-2111
yasushis@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Sato |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Medical Oncology and Hematology
Zip code
Address
S-1,W-16,Sapporo
TEL
011-611-2111
Homepage URL
yasushis@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yasushi Sato
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
| 2014 | Year | 05 | Month | 13 | 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
| 2012 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | 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
| 2014 | Year | 05 | Month | 13 | Day |
Last modified on
| 2014 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016253
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
