UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004086 |
|---|---|
| Receipt number | 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 11:53:00 |
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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
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
Sponsor or person
Institute
Yodogawa Christian Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004904
