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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000003933
Receipt No. R000004728
Scientific Title Phase II trial of amrubicin and cisplatin chemotherapy for invasive thymoma
Date of disclosure of the study information 2010/08/01
Last modified on 2019/01/25

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Basic information
Public title Phase II trial of amrubicin and cisplatin chemotherapy for invasive thymoma
Acronym Amrubicin and cisplatin for invasive thymoma
Scientific Title Phase II trial of amrubicin and cisplatin chemotherapy for invasive thymoma
Scientific Title:Acronym Amrubicin and cisplatin for invasive thymoma
Region
Japan

Condition
Condition thymoma
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of amrubicin plus cisplatin for invasive thymoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Objective response rate
Key secondary outcomes Overall survival, safety

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 amrubicin and cisplatin
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 Histologically confirmation of invasive recurrent or metastatic thymoma
Tumor has measureble lesion as per
RECIST (v1.1).
ECOG PS 0-1
Adult patient(>20 year of age)
No previous chemotherapy and immunotherapy was received
At least 4 weeks since prior surgery or radiation therapy.
Adequate organ function.
White blood cell count >= 4000/mm3
Absolute neutrophil count (ANC)>= 2000/mm3
and platelet count>= 100,000/mm3
Hemoglobin >= 10 gm/Dl
Total bilirubin <= 1.5mg/dl
AST, ALT must be <= 100IU/L
Creatinine <= 1.5 mg/d
PaO2 :>=60Torr
Thymoma associated paraneoplastic syndrome was clinically controlled.
Key exclusion criteria Other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection)
pregnant, or lactating women
active bacterial infection
Severe, medical condition unstable cardiac disease despite of adequate management myocardial infarction within 6 months.
Uncontorllable diabetes mellitus or hypertension or glaucoma.
Interstitial lung diesease
Active ulcer disease
Continuers corticosteroids therapy.
Uncontrolled Psychiatric problem which decrease treatment
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keita Kudo
Organization National Hospital Organization Osaka Minami Medical Center
Division name Department of respiratory medicine
Zip code
Address 2-1, Kidohigashimachi, Kawachi-Nagano-City
TEL 0721-53-5761
Email keita.k@ommc-hp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization None
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
2010 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2010 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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
2010 Year 07 Month 21 Day
Last modified on
2019 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004728

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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