UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003803 |
|---|---|
| Receipt number | 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 17:39:29 |
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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
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
ishihiro@sapmed.ac.jp
Sponsor or person
Institute
Department of 4th Internal medicine,Sapporo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004315
