UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012983
Receipt No. R000007755
Scientific Title The maintenance therapy by Gemcitabine after the Gemcitabine(GEM)+Cisplatin (CDDP) combined therapy over a postoperative recurrence / advanced biliary tract cancer:a phase II, multicenter study
Date of disclosure of the study information 2014/01/28
Last modified on 2014/01/28

* 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 The maintenance therapy by Gemcitabine after the Gemcitabine(GEM)+Cisplatin (CDDP) combined therapy over a postoperative recurrence / advanced biliary tract cancer:a phase II, multicenter study
Acronym The maintenance therapy by Gemcitabine after the Gemcitabine(GEM)+Cisplatin (CDDP) combined therapy over a postoperative recurrence / advanced biliary tract cancer:a phase II, multicenter study
Scientific Title The maintenance therapy by Gemcitabine after the Gemcitabine(GEM)+Cisplatin (CDDP) combined therapy over a postoperative recurrence / advanced biliary tract cancer:a phase II, multicenter study
Scientific Title:Acronym The maintenance therapy by Gemcitabine after the Gemcitabine(GEM)+Cisplatin (CDDP) combined therapy over a postoperative recurrence / advanced biliary tract cancer:a phase II, multicenter study
Region
Japan

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

Objectives
Narrative objectives1 To examine the safety of the maintenance therapy by Gemcitabine after the Gemcitabine(GEM)+Cisplatin (CDDP) combined therapy over a postoperative recurrence / advanced biliary tract cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes progression-free survival
Key secondary outcomes

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 GEM+CDDP combination therapy
GEM: 1,000mg/m2, day1,8
CDDP: 25mg/m2, day1,8
repeated every 3 weeks x 6 cycles

GEM: 1,000mg/m2, day1,8,15
repeated every 4 weeks until PD.
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 unresectable or post-operative recurrent biliary tract cancer
2) Patients with pathologically proven biliary tract cancer
3) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2
4) Patients of age >= 20 years
5) Patients with the treatment except the operation is not provided(excepted biliary drainase)
6) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, neutrophil >= 1,500/mm3, platelet count >= 100,000/mm3, hemoglobin >= 10g/dl, total bilirubin <= 2 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, creatinine clearance >= 45ml/minute
7) Patients who expect to survive more than three months.
8) Written informed consent is required from all patients.
Key exclusion criteria 1) Patients with an active concomitant malignancy
2) Patients with a previous history of a severe drug hypersensitivity
3) Patients with severe comobidities (pulmonary fibrosis or interstitial pneumonia, cardiovascular failure, renal failure, hepatic failure, hemorrhagic digestive ulcer, and gastrointestinal bleeding, intestinal tract paralysis, ileus, uncontrollable diabetes ).
4) Patients with an active concomitant infection
5) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception
6) Patients with a severe mental disorder
7) Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Kawamoto
Organization Kawasaki Medical School
Division name General Internal Medicine 2
Zip code
Address 2-1-80,Nakasange,Kita-ku,Okayama
TEL 086-225-2111
Email hirofumi.kawamoto@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hirofumi Kawamoto
Organization Kawasaki Medical School
Division name General Internal Medicine 2
Zip code
Address 2-1-80,Nakasange,Kita-ku,Okayama
TEL 086-225-2111
Homepage URL
Email hirofumi.kawamoto@gmail.com

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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
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
2014 Year 01 Month 28 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
2011 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 04 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
2014 Year 01 Month 28 Day
Last modified on
2014 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007755

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.