UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007520 |
|---|---|
| Receipt number | 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 | 2022/05/19 21:56:38 |
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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
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
takaharan-int@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008881
