UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007573
Receipt No. R000008638
Scientific Title Combination chemotherapy with CPT-11 amd S-1 in patients with unresectable advanced and recurrent biliary tract cancer
Date of disclosure of the study information 2012/03/30
Last modified on 2012/03/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Combination chemotherapy with CPT-11 amd S-1 in patients with unresectable advanced and recurrent biliary tract cancer
Acronym Combination chemotherapy with CPT-11 amd S-1 in patients with unresectable advanced and recurrent biliary tract cancer
Scientific Title Combination chemotherapy with CPT-11 amd S-1 in patients with unresectable advanced and recurrent biliary tract cancer
Scientific Title:Acronym Combination chemotherapy with CPT-11 amd S-1 in patients with unresectable advanced and recurrent biliary tract cancer
Region
Japan

Condition
Condition Unresectable and recurrent biliary tract cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of CPT-11 / S-1 combination therapy in patients with gemcitabine refractory unresectable advanced and recurrent biliary tract cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes adverse events
serious adverse events
progression-free survival
overall survival

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 CPT-11 60mg/m2 is administered as intravenous infusion 30min on day1, day8. S-1(60mg/m2) is given oral for 14 days followed by a week rest.The cycle is repeated every 3 weeks until disease progression.
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 non-resectable or post-operative recurrent biliary tract cancer including intrahepatic cholangiocarcinoma
2) Patients with pathologically proven or graphically confirmed biliary tract cancer
3) Patients with advanced biliary tract cancer refractory to gemcitabine.
4) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2
5) Patients of age >= 20 years
6) 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.
7) Written informed consent is required from all patients.
Key exclusion criteria 1) Patients with an active concomitant infection
2) Patients with digestive ulcer or gastrointestinal bleeding
3) Patients with severe cardiovascular or renal disease
4) Patients with an active pulmonary fibrosis or interstitial pneumonia
5) Patients with uncontrollable massive pleural effusion or massive ascites
6) Patients with an active concomitant malignancy
7) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception
8) Patients with a previous history of a severe drug hypersensitivity
9) Patients receiving anti-cancer drugs
10) Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Itaru Endo
Organization Yokohama City University
Division name Department of Gastroenterological Surgery
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Kanagawa
TEL 045-787-2650
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama City University
Division name Department of Gastroenterological Surgery
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Kanagawa
TEL 045-787-2650
Homepage URL
Email

Sponsor
Institute Yokohama City University Department of Gastroenterological Surgery
Institute
Department

Funding Source
Organization Yokohama City University
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

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 30 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 No longer recruiting
Date of protocol fixation
2011 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2011 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 25 Day
Last modified on
2012 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008638

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.