UMIN-CTR Clinical Trial

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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