UMIN-CTR Clinical Trial

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	Terminated
Date of protocol fixation	2012 Year 03 Month 15 Day
Date of IRB	2012 Year 03 Month 15 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
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	2022 Year 05 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008881