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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000003803
Receipt No. R000004315
Scientific Title Phase 1/2 trial of oral S-1 plus hepatic intra-arterial Gemcitabine in unresectable biliary cancer
Date of disclosure of the study information 2010/07/01
Last modified on 2015/01/24

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Basic information
Public title Phase 1/2 trial of oral S-1 plus hepatic intra-arterial Gemcitabine in unresectable biliary cancer
Acronym Phase 1/2 trial of oral S-1 plus hepatic intra-arterial Gemcitabine in unresectable biliary cancer
Scientific Title Phase 1/2 trial of oral S-1 plus hepatic intra-arterial Gemcitabine in unresectable biliary cancer
Scientific Title:Acronym Phase 1/2 trial of oral S-1 plus hepatic intra-arterial Gemcitabine in unresectable biliary cancer
Region
Japan

Condition
Condition Unresectable Biliary cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the safety and the efficacy of hepatic intra-arterial infusion of gemcitbine combined with oral S-1 in patients with unresectable biliary cacinomas.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Phase1 safty
Phase2 anti-tumor effect(response rate)
Key secondary outcomes Progression-free survival
Overall survival
Drug administration 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 Hepatic intra-arterial Gemcitabine : 1000mg/m2
(Day1,8)
TS1 : 60-80mg/m2
(Day1-4)
21days cycle
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1.Histologically confirmed as Biliary cancer.
2.No indication for surgical resection.
3.Recurrent cancer with liver metastases.
4.No previous chemotherapy and radiotherapy.
5.Patients with clinically significant refractory ascites or pleural effusion
6. Performance status(ECOG) is 0~2.
7. Survival is expected over 3 months.
8. Patients have an ability for a sufficient oral intake .
9. Function of main organ are enough.
10. Sign the letter of consent by voluntary agreement.
Key exclusion criteria 1. Patienta with a medical history of severe hypersensitivity .
2. With severe allergy for GEM or TS-1.
3. Patients under treatment with flucytosine, phenytoin or warfarin potassium .
4. With steroid.
5. Active infection
6. Severe diarrhea.
7. Active double cancer.
8,9. Patients who are pregnant,lactating or are suspected to be a pregnant
10. With hepatomesenteric-type Variation of Hepatic artery.
11. With pulmonary fibrosis
12,13. With severe heart disease
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotoshi Ishiwatari
Organization Sapporo Medical University
Division name Department of 4th Internal medicine
Zip code
Address West-16,South-1,Chuoku,Sapporo,Hokkaido,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirotoshi Ishiwatari
Organization Sapporo Medical University
Division name Department of 4th Internal medicine
Zip code
Address
TEL
Homepage URL
Email ishihiro@sapmed.ac.jp

Sponsor
Institute Department of 4th Internal medicine,Sapporo Medical University
Institute
Department

Funding Source
Organization Department of 4th Internal medicine,Sapporo Medical University
Organization
Division
Category of Funding Organization Other
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 札幌医科大学附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 07 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 Main results already published
Date of protocol fixation
2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
2012 Year 07 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 06 Month 22 Day
Last modified on
2015 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004315

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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