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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004230
Receipt No. R000005085
Scientific Title Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients
Date of disclosure of the study information 2010/10/01
Last modified on 2014/04/24

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Basic information
Public title Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients
Acronym Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients
Scientific Title Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients
Scientific Title:Acronym Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients
Region
Japan

Condition
Condition Thymic carcinoma
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of nedaplatin plus gemcitabine in previously treated advanced thymic carcinoma patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate
Key secondary outcomes Overall survival, progression-free survival, adverse events

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 administration of nedaplatin and gemcitabine
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Historogically or cytologically confirmed thymic carcinoma.
2)Unresectable disease or recurrent disease after surgery.
3)One or more prior chemotherapy or chemoradiotherapy.
4)Measurable by RECIST criteria.
5)ECOG Performance status of 0-2.
6)Sufficient organ functions.
1.WBC >= 4000/mm3
2.neutrophil >= 2000/mm3
3.Hb >= 9.0g/dL
4.Plt >= 100000/mm3
5.T-bil < 1.5mg/dL
6.AST, ALT < 100IU/L
7.Cr < 1.5mg/dL
8.PaO2 >= 60Torr or SpO2 >= 90%
7)Expected to live over 3 months
8)Written informed consent.
Key exclusion criteria 1)Symptomatic brain metastasis
2)Poorly controlled pleural or pericardial effusion.
3)Need for thoracic radiation.
4)History of double cancer within 5 years.
5)Serious complications.
1.Uncontrollable heart disease (heart failure, ischemic heart disease).
2.History of myocardial infarction within 6 months.
3.Interstitial pneumonia or pulmonary fibrosis detectable on chest X ray.
4.Uncontrollable diabetes mellitus.
5.Uncontrollable hypertension.
6.Active infection.
6)History of severe allergy.
7)Previous administration of nedaplatin or gemcitabine.
8)Now pregnant or lactation.
9)Judged to be not suitable by the attending physician.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shintaro Kanda
Organization Shinshu University School of Medicine
Division name First Department of Internal Medicine
Zip code
Address 3-1-1 Asahi, Matsumoto, Japan
TEL 0263-37-2631
Email shintarokanda@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shintaro Kanda
Organization Shinshu University School of Medicine
Division name First Department of Internal Medicine
Zip code
Address 3-1-1 Asahi, Matsumoto, Japan
TEL 0263-37-2631
Homepage URL
Email shintarokanda@gmail.com

Sponsor
Institute First Department of Internal Medicine, Shinshu University School of Medicine
Institute
Department

Funding Source
Organization Shinshu University Hospital
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 10 Month 01 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 Enrolling by invitation
Date of protocol fixation
2010 Year 09 Month 06 Day
Date of IRB
Anticipated trial start date
2010 Year 09 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 09 Month 17 Day
Last modified on
2014 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005085

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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