UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004029 |
|---|---|
| Receipt number | 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 21:35:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
(≥1.25, <1.50m2), or 60mg (≥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
(≥1.25, <1.50m2), or 60mg (≥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
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
m_ota@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Gastroenterological surgery
Institute
Department
Personal name
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
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
Value
https://center6.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 |
