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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007697
Receipt No. 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

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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
Email 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
Email miyahide@faculty.chiba-u.jp

Sponsor
Institute Chiba surgical oncology development association
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009014

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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