UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007697 |
|---|---|
| Receipt number | R000009014 |
| Scientific Title | The randomized phaseII study of SOX and SIR sequential therapy as TS-1 based regimens in Advanced Colorectal Cancer; WSTAR trial |
| Date of disclosure of the study information | 2012/04/10 |
| Last modified on | 2019/01/28 20:00:01 |
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Basic information
Public title
The randomized phaseII study of SOX and SIR sequential therapy as TS-1 based regimens in Advanced Colorectal Cancer; WSTAR trial
Acronym
SOAC-1102(WSTAR)
Scientific Title
The randomized phaseII study of SOX and SIR sequential therapy as TS-1 based regimens in Advanced Colorectal Cancer; WSTAR trial
Scientific Title:Acronym
SOAC-1102(WSTAR)
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examination of the change medical treatment for SOX +/- molecular target drug therapy and SIR +/- molecular target drug therapy in recurrence colon cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival:OS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1st line chemotheraypy: SOX+Bmab
Bmab: 7.5mg/kg every 3weeks
L-OHP: 130mg/m2 every 3weeks
TS-1: 80-120mg/day 14days on, 7days off
21st 1 course.
2nd line chemotheraypy: SIR+Bmab
Bmab: 7.5mg/kg every 3weeks
CPT-11: 150mg/m2 every 3weeks
TS-1: 80-120mg/day 14days on, 7days off
21st 1 course.
Interventions/Control_2
2nd line chemotherapy: choose either (did not use by)
1)SIR+Bmab
Bmab: 7.5mg/kg every 3 weeks
CPT-11: 150mg/m2 every 3weeks
TS-1: 80-120mg/day 14days on, 7 days off
21st 1 course.
2) SIR+Cmab
Cmab: 250mg/m2 every week
CPT-11: 150mg/m2 every 3 weeks
TS-1: 80-120mg/day 14days on, 7days off
21st 1 course.
3)SIR+Pmab
Pmab: 6mg/kg every 2 weeks
CPT-11: 150mg/m2 every 3 weeks
TS-1: 80-120mg/day 14days on, 7days off
21st 1 course
4)SIR
CPT-11: 150mg/m2 every 3 weeks
TS-1: 80-120mg/day 14days on, 7 days off
21st 1 course.
5)SOX+Bmab
Bmab: 7.5mg/kg every 3 weeks
L-OHP: 130mg/m2 every 3 weeks
TS-1: 80-120mg/day 14days on, 7 days off
21st 1 course.
6)SOX+Cmab
Cmab: 250mg/m2 every 2 weeks
L-OHP: 130mg/m2 every 3 weeks
TS-1: 80-120mg/day 14days on, 7days off
21st 1 course.
7)SOX+Pmab
Pmab: 6mg/kg every 2 weeks
L-OHP: 130mg/m2 every 3 weeks
TS-1: 80-120mg/day 14 days on, 7days off
21st 1 course
8)SOX
L-OHP: 130mg/m2 every 3 weeks
TS-1: 80-120mg/day 14 days on, 7days off
21st 1 course
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Confirmed adenocarcinoma
2) Unresectable colon or rectal cancer
3) 20 >=, <80 years old
4) Performance status(ECOG): 0-1
5) Evaluable lesion by CT, MRI and X-ray within 30 days
6) No previous treatment
7) No abnormally electrocardiogram
8) Oral intake is possible
9) Adequate organ fanction
10) Written informed consent
Key exclusion criteria
1) Serious drug hypersensitivity
2) Pregnant or nursing
3) Active infection
4) Serious coexisting illness
diabetes mellitus, uncontrolled or controlled with insulin, uncontrolled hypertension, liver cirrhosis, renal disfaunction, severe pulmonary dysfunction, active infection, history of myocardial infarction
5) Gastrointestinal ulcer or bleeding
6) Sensory neuropathy
7) Hydrothorax or ascites which needs treatment
8) Brain metastasis
9) Gastrointestinal perforation within 6 months
10) Cerebral infarction, myocardial infarction, pulmonary infarction and interstitial pneumonia
11) Operation within 28 dys
12) Congenital bleeding factor
13) Anticoagulation drugs are given to
14) Active synchronous or metachronous malignancy other than carcinoma in situ
15) Past of the hemoptysis
16) Case having the primary lesion genesis with high stenosis
17) The case that peritoneum dissemination or a peritoneum nodule is confirmed with an image
18) Case taking Flucytosine or Atazanavir Sulfate
19) Diarrea
20) Choloplania
21) The continuous case that receive it systematically of the steroid
22) Atopic dermatitis
23) Not suitable for participating in the study for any other reason
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisahiro Matsubara |
Organization
Chiba graduate school of medicine
Division name
Department of frontier surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2110
matsuhm@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyauchi |
Organization
Chiba surgical oncology development association
Division name
The secretariat
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2110
Homepage URL
miyahide@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba surgical oncology development association
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 10 | 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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 09 | Day |
Last modified on
| 2019 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009014
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