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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006396
Receipt No. R000007573
Scientific Title A phase I/II triral of S-1 plus L-OHP for colorectal cancer liver metastases after hepatic resection
Date of disclosure of the study information 2011/09/23
Last modified on 2016/12/09

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Basic information
Public title A phase I/II triral of S-1 plus L-OHP for colorectal cancer liver metastases after hepatic resection
Acronym A phase I/II triral of S-1 plus L-OHP for colorectal cancer liver metastases after hepatic resection
Scientific Title A phase I/II triral of S-1 plus L-OHP for colorectal cancer liver metastases after hepatic resection
Scientific Title:Acronym A phase I/II triral of S-1 plus L-OHP for colorectal cancer liver metastases after hepatic resection
Region
Japan

Condition
Condition colorectal liver metastases
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3-year disease free survival
Key secondary outcomes

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)liver metastasis is histologically diagnosed as colorectal cancer.
2)Curative resection is performed for primary tumors and liver metastasis
3)Primary liver resecion and recurrent liver resection
4)There are no distant metastasis, recurrences except the liver.
5)There is no history of thermocoagulation therapy and cryotherapy for livermetastasis.
6)The age is between 20 years old and 80years old at the registration day.
7)Performance status is 0-2 cases.
8)A major organ function is maintained by a laboratory study within 14 days before registration.
9)The oral intake of the drug is possible.
10)Treatment can start within eight weeks after an operation.
11)An agreement is obtained in a document from the patients
Key exclusion criteria 1)Surgical stump was clearly positive.
2)Case with the history of usage of S-1 or the L-OHP
3)Multiple primary cancer
4)Serious postoperative complications
5)Case with the following complications
-In insulin therapy or diabetes mellitus inadequate control
-Poor control hypertension (systolic blood pressure more than 180mmHg)
-Heart failure within six months, myocardial infarction, angina and remarkable electrocardiogram abnormal.
-Severe liver disease
-Severe renal disease
-Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema
5)Active infection
6)Peripheral sensory nerve disorder
7)Peripheral sensory nerve disorder
8)Previous serious drug hypersensitivity
9)The case that uses flucytosine, phenytoin, warfarin potassium
10)A pregnant woman or the women who may be pregnant. Men in hope of the pregnancy of the partner.
11)The patients complicated with psychosis or neurologic manifestation, and judged to have difficulty in participation in clinical trials
12)The case judged to be unsuitable for registration
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Kokudo
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,
Graduate School of Medicine, University of Tokyo,
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)

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
2011 Year 09 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2011 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2011 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
2011 Year 09 Month 23 Day
Last modified on
2016 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007573

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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