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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004029
Receipt No. R000004839
Scientific Title Multicenter randomized phase II trial of S-1/ L-OHP (SOX) as an adjuvant treatment after resection of liver metastasis from colorectal carcinoma
Date of disclosure of the study information 2010/09/01
Last modified on 2010/08/10

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Basic information
Public title Multicenter randomized phase II trial of S-1/ L-OHP (SOX) as an adjuvant treatment after resection of liver metastasis from colorectal carcinoma
Acronym Randomized phase II trial of S-1/ L-OHP (SOX) as an adjuvant treatment after resection of liver metastasis from colorectal carcinoma
Scientific Title Multicenter randomized phase II trial of S-1/ L-OHP (SOX) as an adjuvant treatment after resection of liver metastasis from colorectal carcinoma
Scientific Title:Acronym Randomized phase II trial of S-1/ L-OHP (SOX) as an adjuvant treatment after resection of liver metastasis from colorectal carcinoma
Region
Japan

Condition
Condition Cases with liver metastasis from colorectal carcinoma, which is removed curatively and surgically
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of S-1/ L-OHP(SOX) as adjuvant chemotherapy after resection of liver metastasis from colorectal carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Discontinuation rate associated with toxicity
Key secondary outcomes Relapse-free survival
Disease-free survival
Toxicity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oxaliplatin(130mgm-2) was administered as a 2-h infusion every 3 weeks.
Patients received S-1 orally twice daily from the evening of day 1 to
the morning of day 15 at a dose of 40 mg (BSA<1.25m2), 50 mg
(&#8805;1.25, <1.50m2), or 60mg (&#8805;1.50m2) followed by a 7-day rest
period in the 3-weekly schedule.
Interventions/Control_2 Oxaliplatin(100mgm-2) was administered as a 2-h infusion every 3 weeks.
Patients received S-1 orally twice daily from the evening of day 1 to
the morning of day 15 at a dose of 40 mg (BSA<1.25m2), 50 mg
(&#8805;1.25, <1.50m2), or 60mg (&#8805;1.50m2) followed by a 7-day rest
period in the 3-weekly schedule.
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 Patients undergoing first resection for liver metastasis from colorectal carcinoma. No residual disease after surgery and no disease except for liver metastasis and the primary colorectal carcinoma.
Key exclusion criteria The patients with other malignant disease, post-operative severe complications, and surgical margin positivity.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuyoshi Ota
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterological surgery
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2650
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuyoshi Ota
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterological surgery
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2650
Homepage URL
Email m_ota@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine
Gastroenterological surgery
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine
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 09 Month 01 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 Open public recruiting
Date of protocol fixation
2010 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
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 10 Day
Last modified on
2010 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004839

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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