UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The randomized phaseII study of SOX and SIR sequential therapy as TS-1 based regimens in Advanced Colorectal Cancer; WSTAR trial
Title of the study (Brief title)	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	Hisahiro Matsubara
Organization	Chiba graduate school of medicine
Division name	Department of frontier surgery
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	Hideaki Miyauchi
Organization	Chiba surgical oncology development association
Division name	The secretariat
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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