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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002824
Receipt No. 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

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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
Email 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
Email s-kokura@koto.kpu-m.ac.jp

Sponsor
Institute Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002968

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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