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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007520
Receipt No. R000008881
Scientific Title Feasibility study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced biliary tract cancer with carcinomatous ascites.
Date of disclosure of the study information 2012/03/21
Last modified on 2014/12/09

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Basic information
Public title Feasibility study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced biliary tract cancer with carcinomatous ascites.
Acronym Feasibility study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced biliary tract cancer with carcinomatous ascites.
Scientific Title Feasibility study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced biliary tract cancer with carcinomatous ascites.
Scientific Title:Acronym Feasibility study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced biliary tract cancer with carcinomatous ascites.
Region
Japan

Condition
Condition Advanced biliary tract cancer with carcinomatous ascites
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 efficacy and the safety of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced biliary tract cancer with carcinomatous ascites.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression-free survival
Anti-tumor effect(Response rate, Disease control rate)
Effect for carcinomatous ascites
One-year survival rate
Drug administration compliance(Drug intensity, Drug feasibility)

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 40mg/m2 is administered orally twice a day from day 1 to day 14 followed by a one-week rest.Paclitaxel 50mg/m2 is administered intravenously and paclitaxel 20mg/m2 is administered intraperitoneally on days 1 and 8. The cycle is repeated every 3 weeks until evidence of disease progression, patient refusal or unacceptable toxicity.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with pathologically confirmed biliary tract cancer
2) Patients with cytologically confirmed cacinomatous ascites
3) Patients of age >= 20 years
4) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2
5) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal, and creatinine clearance >= 50ml/min. no abnormal clinical findings in ECG.
6) Patients have an ability for a sufficient oral intake
7) Patients refractory to gemcitabine
8) Patients recovery from prior adverse events
9) Written informed consent is required from all patients.
Key exclusion criteria 1) Patients with synchronous or metachronous concomitant malignancies
2) Patients with uncontrolled diabetes mellitus
3) Patients with uncontrolled hypertension
4) Patients with renal failure undergoing hemodialysis
5) Patients with prior myocardial infarction or unstable angina within 6 months
6) Patients with liver cirrhosis
7) Patients with intestinal pneumonia, pulmonary fibrosis, and severe pulmonary emphysema
8) Pregnant or lactating female and patients who is considering pregnancy
9) Patients with contraindication for S-1 or paclitaxel
10) Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Isayama
Organization The University of Tokyo
Division name Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email isayama-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naminatsu Takahara
Organization The University of Tokyo
Division name Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email takaharan-int@h.u-tokyo.ac.jp

Sponsor
Institute The 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 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 21 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
2012 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 03 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
2012 Year 03 Month 16 Day
Last modified on
2014 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=R000008881

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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