UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012983 |
|---|---|
| Receipt number | 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 08:58:26 |
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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
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
hirofumi.kawamoto@gmail.com
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007755
