UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002824 |
|---|---|
| Receipt number | R000002968 |
| Scientific Title | A phase II trial of combination therapy of gemcitabine and hyperthermia in unresectable gallbladder cancer. |
| Date of disclosure of the study information | 2009/12/03 |
| Last modified on | 2015/10/11 13:11:25 |
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Basic information
Public title
A phase II trial of combination therapy of gemcitabine and hyperthermia in unresectable gallbladder cancer.
Acronym
Combination therapy of gemcitabine and hyperthermia in unresectable gallbladder cancer.
Scientific Title
A phase II trial of combination therapy of gemcitabine and hyperthermia in unresectable gallbladder cancer.
Scientific Title:Acronym
Combination therapy of gemcitabine and hyperthermia in unresectable gallbladder cancer.
Region
| Japan |
Condition
Condition
unresectable gallbladder cancer
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 clinical efficacy and safety of the combination of GEM and hyperthermia in unresectable gallbladder cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
survival time, progression-free survival time, safety, performance status
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
One cycle of the chemotherapy regimen consist of a drip infusion of 1000mg/m2 of GEM weekly for 3 weeks and 1 week off, and this was repeated every 4 weeks. Patients receive hyperthermia once per week, each session is scheduled for the day after administratin of GEM, employing radio frequency capacitive heating; Thermotron RF8. The duration of heating session is from 40 minutes to 60 minutes.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligible criteria in this study are as follows:
1.Histologically confirmed unresectable gallbladder cancer
2.Existing measurable lesion(more than two times thickness slice resolution with CT)
3.Over 20, and under 80 years of age
4.Without active other malignancy
5.No prior treatment(radiation therapy,chemotherapy,immunotherapy) for gallbladder cancer
6.PS is 0, 1 or 2
7.Sufficient functions of main organ (bone marrow, kidney, heart)
8.Without severe complications or inadequate physical condition, as diagnosed by primary physician
9.Written informed consent
Key exclusion criteria
Exclusion criteria in this study are as follows:
1. Interstitial pneumonitis, pulmonary fibrosis with radiological findings
2.Presence of uncontrolled diabetes, severe liver dysfunction, unstable angina, myocardial infarction within three months.
3.Presence of active severe infection
4.Pregnant, lactating women or women with suspected pregnancy.
5.Medical history of severe hypersensitivity.
6.Severe complications
7.Inappropriate patients for this study judged by the physicians.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Kokura |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5519
s-kokura@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Kokura |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5519
Homepage URL
s-kokura@koto.kpu-m.ac.jp
Sponsor or person
Institute
Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hyakumanben clinic
Name of secondary funder(s)
Hyakumanben clinic
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
| 2009 | Year | 12 | Month | 03 | 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
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 02 | Day |
Last modified on
| 2015 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002968
