UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003933 |
|---|---|
| Receipt number | 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 | 2023/06/06 10:41:56 |
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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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 17 | Day |
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
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004728
