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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004086
Receipt No. R000004904
Scientific Title S-1 plus Oxaliplatin combination chemotherapy in a stop-and-go fashion for metastatic colorectal cancer
Date of disclosure of the study information 2010/08/30
Last modified on 2018/09/21

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Basic information
Public title S-1 plus Oxaliplatin combination chemotherapy in a stop-and-go fashion for metastatic colorectal cancer
Acronym OPTISOX Study
Scientific Title S-1 plus Oxaliplatin combination chemotherapy in a stop-and-go fashion for metastatic colorectal cancer
Scientific Title:Acronym OPTISOX Study
Region
Japan

Condition
Condition Metastatic colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy in a stop-and-go fashion for metastatic colorectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Frequency and grade of adverse events
Key secondary outcomes Duration of disease control, Tumor response rate, Overall survival, Progression-free survival, Disease control rate, Time to treatment failure, R0 resection rate, Compliance

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 S-1, Oxaliplatin
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Pathologically confirmed colorectal cancer (adenocarcinoma)
2) Unrecetable recurrent or metastatic colorectal cancer
3) Age 20<= 80>
4) PS(ECOG) 0 or 1
5) Presence of tumor region assessed by image test 30 days before the registry (measureable region is not necessary)
6) No prior chemotherapy and radiotherapy
7) Capability of oral intake
8) Sufficient organ functions
WBC>=3000/mm3 and <=12000/mm3
Neutrophils>=1500/mm3
Platelets>=100000/mm3
Hemoglobin>=9.0g/dL
Platelets>=100000/mm3
Total bilirubin<2.0mg/dL
AST<=100IU/L
ALT<=100IU/L
Creatinine Clearance>=60mL/min
9) Expected life over 90 days
10)Written informed consent
Key exclusion criteria 1) Medical history of severe anaphylaxis or allergia to any drug
2) Pregnant or lactating woman at any time during study. Men of the fertility hope.
3) Serious infection
4) Severe complications
5) Severe cardiac disease
6) Neuropathy
7) Severe diarrhea
8) Massive pleural or abdominal effusion
9) High grade stenosis at the primary tumor
10) Presence of peritoneal dissemination
or peritoneal tuberosity assessed by image test
11) Brain metastasis
12) Double cancer
13) Prior adjuvant chemotherapy with oxaliplatin containing regimen
14) Systemic administration of corticosteroids
15) Patients who are judged inappropriate for the entry into the study by the investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Toyokawa
Organization Yodogawa Christian Hospital
Division name Department of surgery
Zip code
Address 2-9-26, Awaji, Higashiyodogawa-ku, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yodogawa Christian Hospital
Division name Department of surgery
Zip code
Address 2-9-26, Awaji, Higashiyodogawa-ku, Osaka, Japan
TEL
Homepage URL
Email

Sponsor
Institute Yodogawa Christian Hospital
Institute
Department

Funding Source
Organization No funding
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
2010 Year 08 Month 30 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
2010 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2013 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 23 Day
Last modified on
2018 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004904

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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